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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003530-33 | EudraCT Number |
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The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.
This is an open-label extension study to assess the long-term safety, tolerability, and efficacy of upadacitinib in adults with RA who have completed Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) Phase 2 randomized controlled trial (RCT) with upadacitinib.
All participants received treatment with 6 mg upadacitinib twice a day at the start of the study. Participants may have been up-titrated to 12 mg BID based on protocol-specified criteria. In Protocol Amendment 2 (January 2016) the study treatment was changed to a once daily (QD) formulation. Participants receiving 6 mg BID were transitioned to 15 mg QD and participants receiving 12 mg BID were transitioned to 30 mg QD dosing.
An optional 12-week vaccine sub-study was added in Protocol Amendment 3 (November 2017) to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background methotrexate on immunological responses to pneumococcal 13-valent conjugate vaccine (PCV-13; Prevnar 13®) in RA patients. The vaccine substudy included 111 participants who were enrolled in the main study, the first participant was enrolled on 13 February 2018 and the the last participant completed the sub-study on 9 April 2020.
In Protocol Amendment 5 (December 2019), the protocol was revised to allow a decrease in upadacitinib dosing from 30 mg QD to 15 mg QD, as appropriate, based on investigator's medical decision or for safety/tolerability concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib | Experimental | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). Participants who did not achieve a 20% improvement from RCT Baseline in both Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 6 or Week 12 were up-titrated to 12 mg BID. From January 2017 participants were transitioned to a once-daily (QD) regimen of upadacitinib, either 15 mg QD (participants who were taking 6 mg BID) or 30 mg QD (participants taking 12 mg BID). Starting with Protocol Amendment 5 participants receiving 30 mg QD upadacitinib had the option to decrease the dose to 15 mg QD at the investigator's discretion. A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Drug | Tablet taken orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. LDA is defined as a DAS28(CRP) score ≤ 3.2. |
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Inclusion Criteria:
Substudy:
Exclusion Criteria:
Pregnant or breastfeeding female.
Ongoing infections at Week 0 that have not been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled but not dosed until the infection has been successfully treated.
Anticipated requirement or receipt of any live vaccine during study participation including up to 30 days after the last dose of study drug.
Laboratory values from the visit immediately prior to Baseline Visit (local requirements may apply) meeting the following criteria:
Enrollment in another interventional clinical study while participating in this study.
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study drug.
Substudy:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheum Assoc of North Alabama /ID# 135926 | Huntsville | Alabama | 35801 | United States | ||
| AZ Arthritis and Rheumotology Research, PLLC /ID# 135902 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37723577 | Derived | Baraliakos X, van der Heijde D, Sieper J, Inman RD, Kameda H, Li Y, Bu X, Shmagel A, Wung P, Song IH, Deodhar A. Efficacy and safety of upadacitinib in patients with ankylosing spondylitis refractory to biologic therapy: 1-year results from the open-label extension of a phase III study. Arthritis Res Ther. 2023 Sep 18;25(1):172. doi: 10.1186/s13075-023-03128-1. | |
| 37199884 |
| Label | URL |
|---|---|
| Related Info. | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing, please refer to the link below.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Participants were assigned to upadacitinib 6 mg twice-daily up to 30 days following the Last Visit (Week 12) of the preceding RCT. Participants may have been up-titrated to 12 mg BID and subsequently down-titrated per protocol-specified criteria. Efficacy results are reported by treatment sequence for each participant. Adverse event data are reported according to treatment received at the time of the event.
Participants may have enrolled in a vaccine substudy during the main study.
Participants must have completed a preceding rheumatoid arthritis (RA) upadacitinib randomized controlled trial (RCT), Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) to be enrolled in this long-term extension study.
Participants were enrolled at 113 study sites located in 17 countries (Belgium, Bulgaria, Chile, Czechia, Hungary, Israel, Latvia, Mexico, New Zealand, Poland, Russian Federation, Slovakia, South Africa, Spain, United Kingdom, Ukraine, and United States/Puerto Rico).
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| ID | Title | Description |
|---|---|---|
| FG000 | Upadacitinib Never Titrated | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to a once-daily (QD) dose of 15 mg upadacitinib and remained on this dose throughout the study. A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2020 | Jun 15, 2022 |
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| Pneumococcal 13-valent conjugate vaccine (PCV-13) | Biological | Administered by intramuscular injection |
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| Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination | Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). | Vaccination Baseline (defined as the last non-missing observation on or before the date of receiving PCV-13 vaccination) and 4 weeks after vaccination |
| Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission is defined as a DAS28(CRP) score < 2.6. | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score ≤ 10. | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Clinical remission is defined as a CDAI score ≤ 2.8. | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. LDA is defined as a SDAI score ≤ 11.0. | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. Clinical remission is defined as a SDAI score ≤ 3.3. | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in Tender Joint Count (TJC68) Over Time | Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a "1" and absence of tenderness as a "0". The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst). | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in Swollen Joint Count (SJC66) Over Time | Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a "1" and absence of swelling as a "0". The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst). | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity. | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in Patient's Assessment of Pain Over Time | Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain." | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement. | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score < 10 means low risk, scores between 10 and 17 indicate medium risk, and scores > 17 indicate high risk of work instability. A negative change from Baseline indicates improvement in work instability. | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status. | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Change From Baseline in EuroQoL-5D VAS Score Over Time | The EQ-5D-5L is a generic measure of health status consisting of two parts. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). A positive change from baseline indicates improvement. | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination | Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). | Vaccination Baseline and 12 weeks after vaccination |
| Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Vaccination Baseline and 4 and 12 weeks after vaccination |
| Phoenix |
| Arizona |
| 85032-9306 |
| United States |
| AZ Arthritis and Rheumotology Research, PLLC /ID# 135931 | Phoenix | Arizona | 85032-9306 | United States |
| C.V. Mehta MD, Med Corporation /ID# 124092 | Hemet | California | 92543 | United States |
| Moores Cancer Center at UC San Diego /ID# 128747 | La Jolla | California | 92093 | United States |
| Desert Medical Advances - Palm Desert /ID# 135911 | Palm Desert | California | 92260 | United States |
| Orrin Troum, M.D. and Medical /ID# 135933 | Santa Monica | California | 90404 | United States |
| Duplicate_Robin K. Dore MD, Inc /ID# 135906 | Tustin | California | 92780 | United States |
| Inland Rheum Clin Trials Inc. /ID# 136716 | Upland | California | 91786 | United States |
| Duplicate_Desert Valley Medical Group /ID# 135932 | Victorville | California | 92395 | United States |
| Denver Arthritis Clinic /ID# 135901 | Denver | Colorado | 80230 | United States |
| New England Research Associates, LLC /ID# 124085 | Bridgeport | Connecticut | 06606-1827 | United States |
| Arthritis & Rheumatic Disease Specialties /ID# 135910 | Aventura | Florida | 33180 | United States |
| Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 124082 | Boca Raton | Florida | 33486 | United States |
| Omega Research Maitland, LLC /ID# 124094 | DeBary | Florida | 32713-2260 | United States |
| University of Florida /ID# 124087 | Jacksonville | Florida | 32209 | United States |
| Suncoast Research Group /ID# 137774 | Miami | Florida | 33135 | United States |
| Omega Research Maitland, LLC /ID# 137398 | Orlando | Florida | 32808 | United States |
| Millennium Research /ID# 135917 | Ormond Beach | Florida | 32174 | United States |
| Arthritis Center, Inc. /ID# 124090 | Palm Harbor | Florida | 34684 | United States |
| IRIS Research and Development, LLC /ID# 140362 | Plantation | Florida | 33324 | United States |
| Lovelace Scientific Resources /ID# 128745 | Venice | Florida | 34292 | United States |
| North Georgia Rheumatology Group /ID# 128746 | Lawrenceville | Georgia | 30045 | United States |
| Kansas City Internal Medicine /ID# 135916 | Overland Park | Kansas | 66209 | United States |
| PRN Professional Research Network of Kansas, LLC /ID# 124091 | Wichita | Kansas | 67205 | United States |
| Klein and Associates MD - Hagerstown /ID# 124086 | Hagerstown | Maryland | 21742 | United States |
| The Center for Rheumatology and Bone Research /ID# 124077 | Wheaton | Maryland | 20902 | United States |
| Clinical Pharmacology Study Group /ID# 124079 | Worcester | Massachusetts | 01605 | United States |
| June DO, PC /ID# 124081 | Lansing | Michigan | 48910 | United States |
| Summit Medical Group /ID# 124076 | Clifton | New Jersey | 07012-1647 | United States |
| Arthritis and Osteoporosis Associates /ID# 135907 | Freehold | New Jersey | 07728-8307 | United States |
| Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 135913 | Voorhees Township | New Jersey | 08043 | United States |
| Arthritis and Osteo Assoc /ID# 132280 | Las Cruces | New Mexico | 88011 | United States |
| DJL Clinical Research, PLLC /ID# 131936 | Charlotte | North Carolina | 28210-8508 | United States |
| Cincinnati Rheumatic Disease Study Group, Inc. /ID# 135921 | Cincinnati | Ohio | 45242-4468 | United States |
| STAT Research, Inc. /ID# 134906 | Vandalia | Ohio | 45377-9464 | United States |
| Health Research of Oklahoma /ID# 135904 | Oklahoma City | Oklahoma | 73103-2400 | United States |
| Duplicate_East Penn Rheumatology Assoc /ID# 135920 | Bethlehem | Pennsylvania | 18015 | United States |
| Altoona Ctr Clinical Res /ID# 124089 | Duncansville | Pennsylvania | 16635 | United States |
| Emkey Arthritis and Osteoporosis Clinic /ID# 135908 | Wyomissing | Pennsylvania | 19610 | United States |
| Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 124080 | Summerville | South Carolina | 29486-7887 | United States |
| Dr. Ramesh Gupta /ID# 128744 | Memphis | Tennessee | 38119 | United States |
| Austin Rheumatology Research /ID# 124083 | Austin | Texas | 78705 | United States |
| Accurate Clinical Management /ID# 128751 | Baytown | Texas | 77521 | United States |
| Accurate Clinical Management /ID# 128752 | Houston | Texas | 77004 | United States |
| Baylor College of Medicine - Baylor Medical Center /ID# 135905 | Houston | Texas | 77030-3411 | United States |
| Houston Institute for Clin Res /ID# 135912 | Houston | Texas | 77074 | United States |
| Accurate Clinical Research /ID# 128753 | Houston | Texas | 77089 | United States |
| Accurate Clinical Research /ID# 128754 | Houston | Texas | 77089 | United States |
| SW Rheumatology Res. LLC /ID# 135927 | Mesquite | Texas | 75150 | United States |
| Mountain State Clinical Research /ID# 124088 | Clarksburg | West Virginia | 26301 | United States |
| Aurora Rheumatology and Immunotherapy Center /ID# 135922 | Franklin | Wisconsin | 53132 | United States |
| UCL Saint-Luc /ID# 139348 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| ReumaClinic Genk-Hasselt /ID# 137775 | Genk | 3600 | Belgium |
| MHAT Trimontsium /ID# 135328 | Plovdiv | 4000 | Bulgaria |
| Duplicate_MHAT Kaspela /ID# 136212 | Plovdiv | 4001 | Bulgaria |
| UHMAT Palmed Plovdiv /ID# 135355 | Plovdiv | 4002 | Bulgaria |
| UMHAT Sveti Ivan Rilski /ID# 135678 | Sofia | 1431 | Bulgaria |
| UMHAT Sveti Ivan Rilski /ID# 136210 | Sofia | 1431 | Bulgaria |
| Diagnostic Consultative Center /ID# 136736 | Sofia | 1612 | Bulgaria |
| Diagnostic consultative center Equita /ID# 136209 | Varna | 9000 | Bulgaria |
| Corporacion de Beneficiencia Osorno /ID# 136189 | Osorno | Los Lagos Region | 1710216 | Chile |
| Quantum Research /ID# 136188 | Puerto Varas | Los Lagos Region | 5550170 | Chile |
| Duplicate_Artroscan s.r.o. /ID# 139347 | Ostrava | 722 00 | Czechia |
| L.K.N. Arthrocentrum, s.r.o /ID# 128782 | Petřkovice | 725 29 | Czechia |
| Revmatologicky ustav v Praze /ID# 137937 | Prague | 128 00 | Czechia |
| Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 137776 | Prague | 140 00 | Czechia |
| Revmatologie Bruntal, s.r.o /ID# 137782 | Prostějov | 796 01 | Czechia |
| Qualiclinic Kft. /ID# 134170 | Budapest | Pest County | 1036 | Hungary |
| Orszagos Reumatologiai es Fizioterapias Intezet /ID# 128785 | Budapest | 1023 | Hungary |
| Szent Margit Szakrendelo /ID# 136676 | Budapest | 1032 | Hungary |
| MAV Korhaz ess Rendelointezet /ID# 139971 | Szolnok | 5000 | Hungary |
| Veszprem Megyei Csolnoky Ferenc Korhaz /ID# 128784 | Veszprém | 8200 | Hungary |
| The Chaim Sheba Medical Center /ID# 139295 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Barzilai Medical Center /ID# 140199 | Ashkelon | 7830604 | Israel |
| M & M Centrs LTD /ID# 132439 | Adazi | LV-2164 | Latvia |
| Arija's Ancane's Family Doctor Practice /ID# 132437 | Baldone | LV-2125 | Latvia |
| Clinic ORTO /ID# 132438 | Riga | LV-1005 | Latvia |
| Clinstile, S.A. de C.V. /ID# 137075 | Cuauhtémoc | Mexico City | 20313 | Mexico |
| Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 137307 | Mexico City | 06090 | Mexico |
| Cliditer SA de CV /ID# 136876 | Mexico City | 06700 | Mexico |
| Timaru Medical Specialists Ltd /ID# 131909 | Timaru | Canterbury | 7910 | New Zealand |
| Waikato Hospital /ID# 131908 | Hamilton | Waikato Region | 3240 | New Zealand |
| Porter Rheumatology Ltd /ID# 133983 | Nelson | 7010 | New Zealand |
| Prywatna Praktyka Lekarska /ID# 128837 | Poznan | Greater Poland Voivodeship | 61-397 | Poland |
| Pratia MCM Krakow /ID# 134749 | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Reum-Medica S.C. /ID# 128841 | Wroclaw | Lower Silesian Voivodeship | 50-244 | Poland |
| Twoja Przychodnia Centrum Medyczne /ID# 128840 | Nowa Sól | Lubusz Voivodeship | 67-100 | Poland |
| NZOZ Lecznica MAK-MED s.c. /ID# 128838 | Nadarzyn | Masovian Voivodeship | 05-830 | Poland |
| Medicome sp. z o.o. /ID# 137397 | Oswiecim | Masovian Voivodeship | 32-600 | Poland |
| NBR Polska /ID# 136208 | Warsaw | Masovian Voivodeship | 00-465 | Poland |
| Centrum Medyczne Amed Warszawa Zoliborz /ID# 128835 | Warsaw | Masovian Voivodeship | 01-518 | Poland |
| Centrum Medyczne Pratia Warszawa /ID# 136650 | Warsaw | Masovian Voivodeship | 01-868 | Poland |
| Centrum Medyczne Reuma Park w Warszawie /ID# 140198 | Warsaw | Masovian Voivodeship | 02-691 | Poland |
| Gabinet Internistyczno-Reumatologiczny /ID# 135876 | Bialystok | Podlaskie Voivodeship | 15-077 | Poland |
| Centrum Medyczne Pratia Gdynia /ID# 137362 | Gdynia | Pomeranian Voivodeship | 81-338 | Poland |
| Ambulatorium Sp. z o.o /ID# 138074 | Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| Duplicate_REUMED Filia nr 2 /ID# 128839 | Lublin | 20-582 | Poland |
| Dr. Ramon L. Ortega-Colon, MD /ID# 128760 | Carolina | 00983 | Puerto Rico |
| GCM Medical Group PSC - Hato Rey /ID# 128759 | San Juan | 00917-3104 | Puerto Rico |
| Mindful Medical Research /ID# 136211 | San Juan | 00918-3756 | Puerto Rico |
| Kazan State Medical University /ID# 136734 | Kazan' | Tatarstan, Respublika | 420012 | Russia |
| Tver Regional Clinical Hospital /ID# 137576 | Tver' | Tver Oblast | 170036 | Russia |
| St. Petersburg Research Institute of Emergency Medicine n.а. I. I. Dzhanelidze /ID# 136652 | Saint Petersburg | 192242 | Russia |
| MEDMAN s.r.o. /ID# 136649 | Martin | 036 01 | Slovakia |
| Poliklinika Senica n.o. /ID# 134728 | Senica | 905 01 | Slovakia |
| Dr MJ Prins /ID# 138540 | Cape Town | Western Cape | 7500 | South Africa |
| Winelands Medical Research Centre /ID# 134669 | Stellenbosch | Western Cape | 7600 | South Africa |
| Clinica Gaias /ID# 133868 | Santiago de Compostela | A Coruna | 15702 | Spain |
| Hospital General Universitario de Elche /ID# 128851 | Elche | Alicante | 03203 | Spain |
| Hospital Infanta Sofia /ID# 136653 | San Sebastián de los Reyes | Madrid | 28702 | Spain |
| Hospital Regional de Malaga /ID# 128847 | Málaga | Malaga | 29010 | Spain |
| Hospital Universitario A Coruna - CHUAC /ID# 128846 | A Coruña | 15006 | Spain |
| Hospital CIMA Sanitas /ID# 128849 | Barcelona | 08034 | Spain |
| Hospital Clinico Universitario San Carlos /ID# 128852 | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Macarena /ID# 128853 | Seville | 41009 | Spain |
| Hospital QuironSalud Infanta Luisa /ID# 135689 | Seville | 41010 | Spain |
| Hospital Universitario Virgen de Valme /ID# 134668 | Seville | 41014 | Spain |
| NSC Strazhesko Ist Cardiology /ID# 137330 | Kiev | 03680 | Ukraine |
| Municipal Non-profit Institution Kyiv City Clinical Hospital No. 3 of the Exec /ID# 137334 | Kyiv | 02125 | Ukraine |
| Warrington and Halton Hospitals NHS Foundation Trust /ID# 137514 | Warrington | Cheshire West And Chester | WA5 1QG | United Kingdom |
| Barts Health NHS Trust /ID# 135683 | London | London, City of | E1 2ES | United Kingdom |
| West Suffolk Hospital /ID# 128858 | Bury St Edmunds | Suffolk | IP33 2QZ | United Kingdom |
| Duplicate_Leeds Teaching Hospitals NHS Trust /ID# 141308 | Leeds | LS9 7TF | United Kingdom |
| Kivitz A, Wells AF, Vargas JI, Baraf HSB, Rischmueller M, Klaff J, Khan N, Li Y, Carter K, Friedman A, Durez P. Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: Final Results from the BALANCE-EXTEND Open-Label Extension Study. Rheumatol Ther. 2023 Aug;10(4):901-915. doi: 10.1007/s40744-023-00557-x. Epub 2023 May 18. |
| 35246470 | Derived | Winthrop K, Vargas JI, Drescher E, Garcia C, Friedman A, Hendrickson B, Li Y, Klaff J, Kivitz A. Evaluation of response to 13-valent conjugated pneumococcal vaccination in patients with rheumatoid arthritis receiving upadacitinib: results from a phase 2 open-label extension study. RMD Open. 2022 Mar;8(1):e002110. doi: 10.1136/rmdopen-2021-002110. |
| FG001 | Upadacitinib Titrated Up and Not Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to a once-daily dose of 30 mg upadacitinib and remained on this dose throughout the study. A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13). |
| FG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13). |
| Enrolled in Vaccine Sub-study |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The open-label treated population consisted of all participants who had received at least one dose of open-label study medication.
Baseline data are from the Baseline of the preceding RCT study (M13-550 or M13-537).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Upadacitinib Never Titrated | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib. |
| BG001 | Upadacitinib Titrated Up and Not Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. |
| BG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Region | Count of Participants | Participants |
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| Duration of RA | Mean | Standard Deviation | years |
| ||||||||||
| Tender Joint Count | A total of 68 joints were assessed for the presence or absence of tenderness. | Mean | Standard Deviation | joints |
| |||||||||
| Swollen Joint Count | A total of 66 joints were assessed for the presence or absence of swelling. | Mean | Standard Deviation | joints |
| |||||||||
| Physician's Global Assessment of Disease Activity | The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity. | Participants with available data | Mean | Standard Deviation | score on a scale |
| ||||||||
| Patient's Global Assessment of Disease Activity | The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity. | Participants with available data | Mean | Standard Deviation | score on a scale |
| ||||||||
| Patient's Global Assessment of Pain | Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain." | Participants with available data | Mean | Standard Deviation | score on a scale |
| ||||||||
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. | Participants with available data | Mean | Standard Deviation | score on a scale |
| ||||||||
| High-sensitivity reactive Protein (hsCRP) | Mean | Standard Deviation | mg/L |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Open-label treated population with available data at each time point | Posted | Number | percentage of participants | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Primary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| Open-label treated population with available data at each time point | Posted | Number | percentage of participants | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Primary | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
| Open-label treated population with available data at each time point | Posted | Number | percentage of participants | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Primary | Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination | Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). | The sub-study full analysis set (FAS) included all participants enrolled in the sub-study who received PCV-13 vaccination and at least 1 dose of upadacitinib 15 mg or 30 mg after vaccination during the sub-study. Analysis includes participants with available data at the Week 4 visit of the sub-study. | Posted | Number | 95% Confidence Interval | percentage of participants | Vaccination Baseline (defined as the last non-missing observation on or before the date of receiving PCV-13 vaccination) and 4 weeks after vaccination |
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| Secondary | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. LDA is defined as a DAS28(CRP) score ≤ 3.2. | Open-label treated population with available data at each time point | Posted | Number | percentage of participants | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time | The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission is defined as a DAS28(CRP) score < 2.6. | Open-label treated population with available data at each time point | Posted | Number | percentage of participants | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score ≤ 10. | Open-label treated population with available data at each time point | Posted | Number | percentage of participants | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Clinical remission is defined as a CDAI score ≤ 2.8. | Open-label treated population with available data at each time point | Posted | Number | percentage of participants | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time | The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. LDA is defined as a SDAI score ≤ 11.0. | Open-label treated population with available data at each time point | Posted | Number | percentage of participants | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time | The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. Clinical remission is defined as a SDAI score ≤ 3.3. | Open-label treated population with available data at each time point | Posted | Number | percentage of participants | Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time | The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time | The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in Tender Joint Count (TJC68) Over Time | Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a "1" and absence of tenderness as a "0". The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst). | Open-label treated population with available data at each time point | Posted | Mean | Standard Deviation | joints | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in Swollen Joint Count (SJC66) Over Time | Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a "1" and absence of swelling as a "0". The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst). | Open-label treated population with available data at each time point | Posted | Mean | Standard Deviation | joints | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in Physician's Global Assessment of Disease Activity Over Time | The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in Patient's Global Assessment of Disease Activity Over Time | The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity. | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in Patient's Assessment of Pain Over Time | Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain." | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time | The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time | Open-label treated population with available data at each time point | Posted | Mean | Standard Deviation | mg/L | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
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| Secondary | Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time | The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement. | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time | RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score < 10 means low risk, scores between 10 and 17 indicate medium risk, and scores > 17 indicate high risk of work instability. A negative change from Baseline indicates improvement in work instability. | Open-label treated population who were currently working at Baseline and at each visit visit and with available data at each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time | The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status. | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQoL-5D VAS Score Over Time | The EQ-5D-5L is a generic measure of health status consisting of two parts. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). A positive change from baseline indicates improvement. | Open-label treated population with available data at Baseline and each time point | Posted | Mean | Standard Deviation | score on a scale | Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination | Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). | The sub-study full analysis set (FAS) included all participants enrolled in the sub-study who received PCV-13 vaccination and at least 1 dose of upadacitinib 15 mg or 30 mg after vaccination during the sub-study. Analysis includes participants with available data at the Week 12 visit of the sub-study. | Posted | Number | 95% Confidence Interval | percentage of participants | Vaccination Baseline and 12 weeks after vaccination |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination | Sub-study full analysis set with available data at each time point. | Posted | Geometric Mean | 95% Confidence Interval | fold-rise | Vaccination Baseline and 4 and 12 weeks after vaccination |
|
|
From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Upadacitinib 6 mg BID/15 mg QD | Participants received upadacitinib 6 mg BID. From January 2017 participants were transitioned to 15 mg upadacitinib QD. Includes events that occurred until the time of up-titration for participants who were up-titrated. | 5 | 493 | 68 | 493 | 233 | 493 |
| EG001 | Upadacitinib 12 mg BID/30 mg QD | Participants received upadacitinib 12 mg BID. From January 2017 participants were transitioned to 30 mg upadacitinib QD. Includes events that occurred from the time of up-titration until time of down titration to 6 mg BID/15 mg QD for participants who titrated up and back down. | 3 | 187 | 42 | 187 | 113 | 187 |
| EG002 | Upadacitinib 6 mg BID/15 mg QD Post Down-titration | Participants who down-titrated to 6 mg BID/15 mg QD after up-titration to 15 mg BID/30 mg QD. Includes events that occurred after down titration. | 0 | 38 | 5 | 38 | 23 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BLOOD LOSS ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| AORTIC VALVE INCOMPETENCE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CARDIOMYOPATHY | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISSECTION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| STRESS CARDIOMYOPATHY | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VESTIBULAR DISORDER | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GOITRE | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CORNEAL PERFORATION | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GLAUCOMA | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MACULAR HOLE | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ENDOMETRITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HEPATITIS A | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HISTOPLASMOSIS DISSEMINATED | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| LATENT TUBERCULOSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| VARICELLA ZOSTER VIRUS INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FOREARM FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| INCARCERATED INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| MULTIPLE FRACTURES | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| MULTIPLE INJURIES | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| POST PROCEDURAL DISCHARGE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SKULL FRACTURED BASE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC COMPRESSION | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SPONDYLOLISTHESIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| CLEAR CELL RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| ENDOMETRIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| HODGKIN'S DISEASE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| INVASIVE BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| INVASIVE LOBULAR BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| INVASIVE PAPILLARY BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA STAGE I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| PAPILLARY THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| SEBACEOUS CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF THE CERVIX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| THYROID B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| BRAIN STEM INFARCTION | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTRACRANIAL ANEURYSM | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LACUNAR INFARCTION | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| METABOLIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| OCCIPITAL NEURALGIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEVICE LOOSENING | Product Issues | MedDRA 24.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DISSOCIATIVE DISORDER | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BLADDER PROLAPSE | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CERVICAL DYSPLASIA | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYDROSALPINX | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LUNG INFILTRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PARANASAL CYST | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABORTION INDUCED | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERY STENOSIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERY THROMBOSIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VENOUS THROMBOSIS | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| LATENT TUBERCULOSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment | The Preferred Term of rheumatoid arthritis was due to the reported term of "worsening of RA" being coded to rheumatoid arthritis. |
|
| HEADACHE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ROSACEA | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2021 | Jun 15, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613732 | upadacitinib |
| C538862 | 13-valent pneumococcal vaccine |
Not provided
Not provided
Not provided
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| Upadacitinib Titrated Up and Down |
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. |
| OG002 | Upadacitinib Titrated Up and Down | Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| OG002 |
| Upadacitinib Titrated Up and Down |
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns. |
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| Participants |
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