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The study objectives of Period 1 of this study were to compare the efficacy, safety, and tolerability of upadacitinib versus placebo for the treatment of signs and symptoms of subjects from China and selected countries including Brazil and South Korea with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs.
The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in subjects with RA who have completed Period 1.
This is a Phase 3 multicenter study that includes two periods. Period 1 is a 12-week, randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib versus placebo for the treatment of signs and symptoms of participants with moderately to severely active RA who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs. Period 2 is an open label 52 week extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in participants with RA who have completed Period 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo / Upadacitinib 15 mg | Placebo Comparator | Participants randomized to receive placebo once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2. |
|
| Upadacitinib 15 mg | Experimental | Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1 and up to an additional 52 weeks in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Drug | Tablets for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) at Week 12 | 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. |
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Inclusion Criteria:
Diagnosis of RA for ≥ 3 months who also fulfill the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for RA.
Participants have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug.
Participant meets both of the following disease activity criteria:
Participants with prior exposure to at most one biological disease-modifying anti-rheumatic drugs (bDMARD) may be enrolled (up to 20% of total number of subjects). Specifically, prior to enrollment:
Participants must have discontinued bDMARD therapy prior to the first dose of study drug.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 152964 | Curitiba | Paraná | 80030-110 | Brazil | ||
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.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Participants who met eligibility criteria were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by country and the Chinese population was expected to comprise up to 80% of the total study population.
Participants were enrolled at 37 sites in Brazil, China, and South Korea.
The study consisted of a 12-week placebo-controlled, double-blind period (Period 1), and an open-label 52-week extension period (Period 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo / Upadacitinib 15 mg | Participants randomized to receive placebo once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2. |
| FG001 | Upadacitinib 15 mg / Upadacitinib 15 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Double-blind Treatment Period |
|
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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 | Oct 17, 2018 | Jul 27, 2020 |
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| Placebo | Drug | Tablets for oral administration |
|
| Baseline and Week 12 |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | 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. A negative change from Baseline in the overall score indicates improvement. | Baseline and Week 12 |
| Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 | The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement. | Baseline and Week 12 |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12 | Low disease activity based on DAS28 (CRP) is defined a DAS28 (CRP) score of ≤ 3.2. The DAS28 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A DAS28 score less than or equal to 3.2 indicates low disease activity. | Week 12 |
| Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12 | Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) score of less than 2.6. 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. | Week 12 |
| Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) at Week 12 | Low disease activity based on CDAI is defined as a CDAI score ≤ 10. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. | Week 12 |
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| Baseline and Week 12 |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
| Baseline and Week 12 |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Baseline and Week 1 |
| Parana Medical Research Center /ID# 153507 |
| Maringá |
| Paraná |
| 87015-000 |
| Brazil |
| LMK Sevicos Medicos S/S /ID# 152963 | Porto Alegre | Rio Grande do Sul | 90480-000 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 152961 | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| CEPIC - Centro Paulista de Investigação ClÃnica e Serviços Médicos Ltda /ID# 152966 | São Paulo | São Paulo | 04266-010 | Brazil |
| 1st Aff Hosp of Bengbu Med Col /ID# 162161 | Bengbu | Anhui | 233099 | China |
| Anhui Provincial Hospital /ID# 161117 | Hefei | Anhui | 230001 | China |
| Zhongshan Hosp. of Fudan Uni. /ID# 161108 | Shanghai | Anhui | 200032 | China |
| The 1st Aff Hosp Xiamen Univ /ID# 162154 | Xiamen | Fujian | 361003 | China |
| Zhuzhou Central Hospital /ID# 162153 | Zhuzhou | Hunan | 412007 | China |
| The First Affiliated Hospital /ID# 163747 | Baotou | Inner Mongolia | 014016 | China |
| The First People's Hospital /ID# 168462 | Changzhou | Jiangsu | 213004 | China |
| The First People's Hospital of Jiujiang /ID# 168461 | Jiujiang | Jiangxi | 332000 | China |
| The First Hosp of Jilin Univ /ID# 161116 | Changchun | Jilin | 130021 | China |
| Jining No.1 People's Hospital /ID# 162158 | Jining | Shandong | 272001 | China |
| Shanghai Changhai Hospital /ID# 161123 | Shanghai | Shanghai Municipality | 200433 | China |
| West China Hospital /ID# 161119 | Chengdu | Sichuan | 610041 | China |
| Xuanwu Hosp Capital Med Univ /ID# 161118 | Beijing | 100053 | China |
| Peking Union Med College Hosp /ID# 161107 | Beijing | 100730 | China |
| The Second Xiangya Hospital of Central South University /ID# 162152 | Changsha | 410000 | China |
| First Affiliated Hospital of Kunming Medical University /ID# 164637 | Kunming | 650032 | China |
| Jiangsu Province Hospital /ID# 161122 | Nanjing | 210029 | China |
| Pingxiang People's Hospital /ID# 162151 | Pingxiang | 337055 | China |
| 1st Aff Hosp of Shantou Univ /ID# 162165 | Shantou Guangdong | 515041 | China |
| The Second Hospital of Shanxi /ID# 162164 | Taiyuan | 030001 | China |
| Tianjin Med Univ General Hosp /ID# 162155 | Tianjin | 300052 | China |
| People's Hospital of Xinjiang /ID# 162157 | Ürümqi | 830001 | China |
| First Affiliated Hospital of Xi'an Jiaotong University /ID# 162150 | Xi'an | 710061 | China |
| SoonChunHyang University CheonAn Hospital /ID# 209078 | Cheonan-si | Chungcheongnam-do | 31151 | South Korea |
| Kyungpook National Univ Hosp /ID# 166919 | Daegu | Daegu Gwang Yeogsi | 41944 | South Korea |
| Chungnam National University Hospital /ID# 167727 | Junggu | Daejeon Gwang Yeogsi | 35015 | South Korea |
| St. Vincent's Hospital /ID# 166918 | Suwon | Gyeonggido | 16247 | South Korea |
| Ajou University Hospital /ID# 163912 | Suwon | Gyeonggido | 16499 | South Korea |
| Inha University Hospital /ID# 163910 | Junggu | Incheon Gwang Yeogsi | 22332 | South Korea |
| Chonnam National University Hospital /ID# 167726 | Gwangju | Jeonranamdo | 61469 | South Korea |
| Kyung Hee University Medical Center /ID# 163908 | Dongdaemun-gu | Seoul Teugbyeolsi | 02447 | South Korea |
| SMG-SNU Boramae Medical Center /ID# 163911 | Dongjak-gu | Seoul Teugbyeolsi | 07061 | South Korea |
| Yonsei University Health System, Severance Hospital /ID# 168421 | Seodaemun-gu | Seoul Teugbyeolsi | 03722 | South Korea |
| Hanyang University Seoul Hospi /ID# 163913 | Seongdong-gu | Seoul Teugbyeolsi | 04763 | South Korea |
| Konkuk University Medical Ctr /ID# 206148 | Seoul | Seoul Teugbyeolsi | 05030 | South Korea |
| The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 204224 | Seoul | Seoul Teugbyeolsi | 07345 | South Korea |
| Asan Medical Center /ID# 163909 | Seoul | 05505 | South Korea |
| Chung-Ang University Hostipal /ID# 209076 | Seoul | 06973 | South Korea |
Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1 followed by upadacitinib 15 mg once daily for up to 52 weeks in Period 2.
| COMPLETED | Completed Period 1 (Week 12) study drug |
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| NOT COMPLETED |
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| Period 2: Open-label Extension |
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The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants randomized to receive placebo once daily for 12 weeks in Period 1. |
| BG001 | Upadacitinib 15 mg | Participants randomized to receive upadacitinib 15 mg once daily for 12 weeks in Period 1. |
| BG002 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Enrollment by Country | Count of Participants | Participants |
| ||||||||||||||||
| Duration Since Rheumatoid Arthritis (RA) Diagnosis | 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 |
| ||||||||||||||
| 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 visual analog scale (VAS) ranging from 0 to 100, where 0 indicates very low disease activity and 100 indicates very high disease activity. | Participants with available data | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| 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 VAS scale from 0 to 100, where 0 indicates very low disease activity and 100 indicates very high disease activity. | Participants with available data | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Patient's 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. A score of 0 indicates "no pain" and a score of 100 indicates "worst possible pain." | Participants with available data | Mean | Standard Deviation | units 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 | units on a scale |
| |||||||||||||
| High-sensitivity C-reactive Protein (CRP) | 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 at Week 12 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
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| Secondary | Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) at Week 12 | 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity. | Full analysis set; multiple imputation was used for missing data. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | 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. A negative change from Baseline in the overall score indicates improvement. | Full analysis set; multiple imputation was used for missing data. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 | The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement. | Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Week 12 |
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| Secondary | Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12 | Low disease activity based on DAS28 (CRP) is defined a DAS28 (CRP) score of ≤ 3.2. The DAS28 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. A DAS28 score less than or equal to 3.2 indicates low disease activity. | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12 | Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) score of less than 2.6. 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 (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to 10, where higher scores indicate more disease activity. | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 (CRP) data were missing at Week 12 were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) at Week 12 | Low disease activity based on CDAI is defined as a CDAI score ≤ 10. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. | Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom CDAI data were missing at Week 12 were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
| Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
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| Secondary | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
| Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 12 |
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| Secondary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1 | Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
| Full analysis set; participants who prematurely discontinued from study drug prior to Week 1 or for whom ACR data were missing at Week 1 were considered non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 1 |
|
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Period 1: From the first dose of study drug up to Week 12 or up to 30 days after last dose for participants who discontinued study drug prior to Week 12. Period 2: From Week 12 to 30 days after last dose; up to 56 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: Placebo | Participants received placebo once daily for 12 weeks in Period 1. | 0 | 169 | 5 | 169 | 13 | 169 |
| EG001 | Period 1: Upadacitinib 15 mg | Participants received upadacitinib 15 mg once daily for 12 weeks in Period 1. | 0 | 169 | 12 | 169 | 25 | 169 |
| EG002 | Period 1+2: Upadacitinib 15 mg | Participants originally assigned to placebo received upadacitinib 15 mg from Week 12 to Week 64. Participants originally assigned to upadacitinib received upadacitinib 15 mg from Week 0 to Week 64. | 0 | 322 | 55 | 322 | 198 | 322 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| SENILE OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| SPINAL LIGAMENT OSSIFICATION | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| SPONDYLOLISTHESIS | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| URETEROLITHIASIS | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA (22.0) | Systematic Assessment |
| |
| DUODENAL ULCER PERFORATION | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| BACTERIAL INFECTION | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| FALLOPIAN TUBE ABSCESS | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| FEBRILE INFECTION | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| PNEUMONIA CRYPTOCOCCAL | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| SINUSITIS FUNGAL | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| FIBULA FRACTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| PATELLA FRACTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| ELECTROLYTE IMBALANCE | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| ACOUSTIC NEUROMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| KAPOSI'S SARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF THE CERVIX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| POST HERPETIC NEURALGIA | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| STRESS URINARY INCONTINENCE | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| ABORTION INDUCED | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| LATENT TUBERCULOSIS | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (22.0) | 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 30, 2019 | Jul 27, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| 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 |
Not provided
Not provided
Not provided
| Lack of Efficacy |
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