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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002306-31 | EudraCT Number |
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Study M16-763 was terminated early as the benefit of each treatment arm from the feeder study (Study M16-063) did not provide appreciable evidence of differentiated clinical effect to warrant further long-term continuation.
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This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy of ABBV-105 (elsubrutinib [ELS]) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).
This was a Phase 2, double-blind, multicenter, long-term extension (LTE) study to assess the safety, tolerability, and efficacy of 3 doses of ABBV-105 (elsubrutinib [ELS] 5 mg, 20 mg, and 60 mg) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in adults with active rheumatoid arthritis with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs). Participants who successfully completed treatment in the feeder Study M16-063, a Phase 2 dose exploratory study, were eligible to participate in this study. Those who met eligibility criteria and entered this study receiving ELS, ABBV-599, or UPA from Study M16-063 continued on their previously assigned treatment through termination of this study. Participants originally randomized to placebo in Study M16-063 rolled over to ABBV-599 in a blinded fashion in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Experimental | 60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks |
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| ABBV-105 60 mg/UPA placebo | Experimental | 60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
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| ABBV-105 20 mg/UPA placebo | Experimental | 20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
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| ABBV-105 5 mg/UPA placebo | Experimental | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
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| UPA 15 mg/ABBV-105 placebo | Experimental | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elsubrutinib | Drug | Elsubrutinib capsule will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either having a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | On or after the first dose of study drug in Study M16-763, and up to 30 days after the last dose of study drug in Study M16-763, up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763 | 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 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint Luc /ID# 207719 | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium | ||
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| 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.
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.
All randomized participants
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| ID | Title | Description |
|---|---|---|
| FG000 | ABBV-599 in M16-063/ABBV-599 in M16-763 | 60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks |
| FG001 | ABBV-105 60 mg/UPA Placebo |
| 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 | Feb 6, 2020 | Aug 18, 2021 |
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| Placebo in M16-063/ABBV-599 in M16-763 | Experimental | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
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| Upadacitinib | Drug | Upadacitinib tablet will be administered orally. |
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| Placebo for elsubrutinib | Drug | Placebo capsule for elsubrutinib will be administered orally. |
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| Placebo for upadacitinib | Drug | Upadacitinib placebo tablet will be administered orally. |
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| Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | 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 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2. | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | 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 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical Remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6. | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | The 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 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | The 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 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a total CDAI score of less than or equal to 10. | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | The 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 78 with higher scores indicating higher disease activity. Complete Remission (CR) based on CDAI is defined as achieving a total CDAI score of less than or equal to 2.8. | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 20% response (ACR20) criteria:
| Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 50% response (ACR50) criteria:
| Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 70% response (ACR70) criteria:
| Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline. | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline. | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Participants rated their pain on a visual analogue scale (VAS) of 0 to 100 (mm), with 0 representing no pain and 100 representing the worst possible pain. Negative values indicate improvement from baseline. | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline. | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | The physician assessed a participant's disease activity at the time of the visit using a Physician's Global Assessment of Disease visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline. | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | 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 in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | C-reactive protein is a blood test marker for inflammation in the body, and levels rise in response to inflammation. A negative change from baseline indicates improvement. | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| Change in Morning Stiffness Severity From Baseline of Study M16-063 | Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline. | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| UZ Leuven /ID# 207722 |
| Leuven |
| 3000 |
| Belgium |
| Rheumatology Research Assoc /ID# 207769 | Edmonton | Alberta | T5M 0H4 | Canada |
| Manitoba Clinic /ID# 206852 | Winnipeg | Manitoba | R3A 1M3 | Canada |
| CIADS Research Co Ltd /ID# 206853 | Winnipeg | Manitoba | R3N 0K6 | Canada |
| Mount Sinai Hosp.-Toronto /ID# 206851 | Toronto | Ontario | M5G 1X5 | Canada |
| Dr. Latha Naik /ID# 213440 | Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| Revmatolog s.r.o. /ID# 209941 | Jihlava | Jihlava | 586 01 | Czechia |
| Revmatologicky ustav Praha /ID# 209943 | Prague | Praha 2 | 128 00 | Czechia |
| Revmatologie MUDr. Klara Sirova /ID# 209944 | Ostrava | 702 00 | Czechia |
| CCR Czech a.s /ID# 209942 | Pardubice | 530 02 | Czechia |
| CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 208186 | Miskolc | Borsod-Abauj Zemplen county | 3529 | Hungary |
| Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 208184 | NyÃregyháza | Szabolcs-Szatmár-Bereg | 4400 | Hungary |
| Revita Reumatologiai Rendelo /ID# 208187 | Budapest | 1027 | Hungary |
| CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 208188 | Székesfehérvár | 8000 | Hungary |
| Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 208185 | Veszprém | 8200 | Hungary |
| Malopolskie Centrum Kliniczne /ID# 209902 | Cracow | Lesser Poland Voivodeship | 30-149 | Poland |
| McBk Sc /Id# 212577 | Grodzisk Mazowiecki | Masovian Voivodeship | 05-825 | Poland |
| NBR Polska /ID# 209904 | Warsaw | Masovian Voivodeship | 00-465 | Poland |
| ClinicMed Daniluk, Nowak Sp.j. /ID# 212578 | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Reumatika - Centrum Reumatologii NZOZ /ID# 209903 | Warsaw | 02-691 | Poland |
| Hospital Universitario A Coruña - CHUAC /ID# 207732 | A Coruña | A Coruna | 15006 | Spain |
| Hospital Unversitario Marques de Valdecilla /ID# 207729 | Santander | Cantabria | 39008 | Spain |
| Hospital Regional de Malaga /ID# 207735 | Málaga | Malaga | 29010 | Spain |
| Hospital Clinic /ID# 207740 | Barcelona | 08036 | Spain |
| Hospital Universitario Basurto /ID# 207737 | Bilbao | 48013 | Spain |
| Hospital Universitario Virgen de las Nieves /ID# 209975 | Granada | 18014 | Spain |
| Hospital Clinico Universitario San Carlos /ID# 207738 | Madrid | 28040 | Spain |
| Hospital Universitario y Politecnico La Fe /ID# 207739 | Valencia | 46026 | Spain |
| University of Oxford /ID# 210571 | Oxford | OX3 7LF | United Kingdom |
60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
| FG002 | ABBV-105 20 mg/UPA Placebo | 20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| FG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| FG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| FG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763
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| ID | Title | Description |
|---|---|---|
| BG000 | ABBV-599 in M16-063/ABBV-599 in M16-763 | 60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks |
| BG001 | ABBV-105 60 mg/UPA Placebo | 60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| BG002 | ABBV-105 20 mg/UPA Placebo | 20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| BG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| BG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| BG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
| BG006 | 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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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Duration of Rheumatoid Arthritis Diagnosis | Mean | Standard Deviation | years |
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| 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 | Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either having a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. | Safety Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 | Posted | Count of Participants | Participants | No | On or after the first dose of study drug in Study M16-763, and up to 30 days after the last dose of study drug in Study M16-763, up to 52 weeks |
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| Secondary | Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763 | 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 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
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| Secondary | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | 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 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
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| Secondary | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | 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 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical Remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
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| Secondary | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | The 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 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
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| Secondary | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | The 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 78 with higher scores indicating higher disease activity. Low Disease Activity (LDA) based on CDAI is defined as achieving a total CDAI score of less than or equal to 10. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
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| Secondary | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | The 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 78 with higher scores indicating higher disease activity. Complete Remission (CR) based on CDAI is defined as achieving a total CDAI score of less than or equal to 2.8. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
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| Secondary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 20% response (ACR20) criteria:
| Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
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| Secondary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 50% response (ACR50) criteria:
| Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Participants who met the following 3 conditions for improvement from baseline of Study M16-063 were classified as meeting the American College of Rheumatology 70% response (ACR70) criteria:
| Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | swollen joint counts | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | tender joint counts | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Participants rated their pain on a visual analogue scale (VAS) of 0 to 100 (mm), with 0 representing no pain and 100 representing the worst possible pain. Negative values indicate improvement from baseline. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Participants rated their disease activity for the past 24 hours using a Patient's Global Assessment of Disease Activity Global visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | The physician assessed a participant's disease activity at the time of the visit using a Physician's Global Assessment of Disease visual analogue scale (VAS). The range is 0 to 100 mm, with 0 representing no disease activity and 100 representing severe disease activity. Negative values indicate improvement from baseline. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | 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: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | C-reactive protein is a blood test marker for inflammation in the body, and levels rise in response to inflammation. A negative change from baseline indicates improvement. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | mg/L | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline. | Full Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763 with available data | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 |
|
All-cause mortality is reported from enrollment to the end of study; median time on follow-up was ABBV-599 in M16-063/M16-763 (279 days); ABBV-105 60 mg/UPA placebo (183 days); ABBV-105 20 mg/UPA placebo (159 days); ABBV-105 5 mg/UPA placebo (337 days); UPA 15 mg/ABBV-105 placebo (229 days); and Placebo in M16-063/ABBV-599 in M16-763 (281 days). TEAEs/SAEs were collected from the first dose in M16-763 until 30 days after last dose, up to 52 weeks.
All-cause mortality and adverse events: all participants who completed Study M16-063 and received at least one dose of assigned study drug in Study M16-763, grouped according to treatments actually received in Study M16-763
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 | ABBV-599 in M16-063/ABBV-599 in M16-763 | 60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks | 0 | 28 | 1 | 28 | 8 | 28 |
| EG001 | ABBV-105 60 mg/UPA Placebo | 60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks | 0 | 16 | 0 | 16 | 10 | 16 |
| EG002 | ABBV-105 20 mg/UPA Placebo | 20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks | 0 | 12 | 0 | 12 | 3 | 12 |
| EG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks | 0 | 12 | 0 | 12 | 5 | 12 |
| EG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks | 0 | 20 | 1 | 20 | 7 | 20 |
| EG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 | 0 | 9 | 0 | 9 | 3 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PERIPROSTHETIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| LUNG ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| MICROCYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DRUG INTOLERANCE | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DRUG WITHDRAWAL SYNDROME | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| URETHRITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| URINE ANALYSIS ABNORMAL | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| RENAL CYST | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 22.1 | 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 | Feb 10, 2020 | Aug 18, 2021 | 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
| Male |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Asian |
|
| ABBV-105 20 mg/UPA Placebo |
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| ABBV-105 20 mg/UPA Placebo |
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| ABBV-105 20 mg/UPA Placebo |
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| ABBV-105 20 mg/UPA Placebo |
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| ABBV-105 20 mg/UPA Placebo |
20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG002 | ABBV-105 20 mg/UPA Placebo | 20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG002 | ABBV-105 20 mg/UPA Placebo | 20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG002 | ABBV-105 20 mg/UPA Placebo | 20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG002 | ABBV-105 20 mg/UPA Placebo | 20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| ABBV-105 5 mg/UPA Placebo |
5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
|
|
| OG003 | ABBV-105 5 mg/UPA Placebo | 5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks |
| OG004 | UPA 15 mg/ABBV-105 Placebo | 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks |
| OG005 | Placebo in M16-063/ABBV-599 in M16-763 | Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763 |
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