Rheumatoid Arthritis (RA)
Conditions
Keywords
Elsubrutinib, ABBV-105, Upadacitinib, ABBV-599, Rheumatoid Arthritis (RA), Long-term extension (LTE)
Brief summary
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).
Detailed description
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.
Interventions
DRUGElsubrutinib
Elsubrutinib capsule will be administered orally.
DRUGUpadacitinib
Upadacitinib tablet will be administered orally.
Placebo capsule for elsubrutinib will be administered orally.
Upadacitinib placebo tablet will be administered orally.
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has completed Study M16-063 * Participant has not developed any laboratory or clinical discontinuation criteria as defined in the Study M16-063 protocol * Participant is willing and/or able to comply with procedures required in the current study protocol
Exclusion criteria
* Participant is currently enrolled or planning to enroll in another interventional clinical study while participating in this study (except the preceding study M16-063) * Participant requires vaccination with any live vaccine during study participation, including at least 30 days after the last dose of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Weeks 18, 24, 30, 36, 48, and 60 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. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2. |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Weeks 18, 24, 30, 36, 48, and 60 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. Clinical Remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6. |
| Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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: 1. ≥ 20% improvement in 68-tender joint count from Baseline of Study M16-063 2. ≥ 20% improvement in 66-swollen joint count from Baseline of Study M16-063 and 3. ≥ 20% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP) |
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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: 1. ≥ 50% improvement in 68-tender joint count from Baseline of Study M16-063 2. ≥ 50% improvement in 66-swollen joint count from Baseline of Study M16-063 and 3. ≥ 50% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP) |
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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: 1. ≥ 70% improvement in 68-tender joint count from Baseline of Study M16-063 2. ≥ 70% improvement in 66-swollen joint count from Baseline of Study M16-063 and 3. ≥ 70% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP) |
| 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 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 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. |
| Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Change in Morning Stiffness Severity From Baseline of Study M16-063 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
| Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763 | 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. |
Countries
Belgium, Canada, Czechia, Hungary, Poland, Spain, United Kingdom
Participant flow
Pre-assignment details
All randomized participants
Participants by arm
| Arm | Count |
|---|---|
| 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 | 28 |
| 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 | 16 |
| 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 | 12 |
| 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 | 12 |
| 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 | 20 |
| 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 | 9 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Other, not specified | 19 | 12 | 6 | 8 | 17 | 7 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 4 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | ABBV-105 60 mg/UPA Placebo | ABBV-105 20 mg/UPA Placebo | ABBV-105 5 mg/UPA Placebo | ABBV-599 in M16-063/ABBV-599 in M16-763 | UPA 15 mg/ABBV-105 Placebo | Placebo in M16-063/ABBV-599 in M16-763 | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 8.75 | 58.5 years STANDARD_DEVIATION 12.07 | 54.5 years STANDARD_DEVIATION 12.21 | 57.5 years STANDARD_DEVIATION 12.64 | 61.7 years STANDARD_DEVIATION 8.99 | 59.4 years STANDARD_DEVIATION 9.48 | 58.5 years STANDARD_DEVIATION 10.89 |
| Duration of Rheumatoid Arthritis Diagnosis | 14.212 years STANDARD_DEVIATION 9.0327 | 5.435 years STANDARD_DEVIATION 3.2458 | 9.466 years STANDARD_DEVIATION 6.6508 | 10.024 years STANDARD_DEVIATION 5.6087 | 13.571 years STANDARD_DEVIATION 7.8086 | 9.684 years STANDARD_DEVIATION 5.6087 | 10.778 years STANDARD_DEVIATION 7.0861 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 12 Participants | 12 Participants | 27 Participants | 20 Participants | 9 Participants | 95 Participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 8 Participants | 18 Participants | 18 Participants | 7 Participants | 77 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 4 Participants | 10 Participants | 2 Participants | 2 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 16 | 0 / 12 | 0 / 12 | 0 / 20 | 0 / 9 |
| other Total, other adverse events | 8 / 28 | 10 / 16 | 3 / 12 | 5 / 12 | 7 / 20 | 3 / 9 |
| serious Total, serious adverse events | 1 / 28 | 0 / 16 | 0 / 12 | 0 / 12 | 1 / 20 | 0 / 9 |
Outcome results
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.
Time frame: 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
Population: Safety Analysis Set: all participants who completed Study M16-063 and received at least 1 dose of assigned study drug in Study M16-763
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Number of Participants With Adverse Events (AEs) | 11 Participants |
| ABBV-105 60 mg/UPA Placebo | Number of Participants With Adverse Events (AEs) | 10 Participants |
| ABBV-105 20 mg/UPA Placebo | Number of Participants With Adverse Events (AEs) | 3 Participants |
| ABBV-105 5 mg/UPA Placebo | Number of Participants With Adverse Events (AEs) | 5 Participants |
| UPA 15 mg/ABBV-105 Placebo | Number of Participants With Adverse Events (AEs) | 7 Participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Number of Participants With Adverse Events (AEs) | 3 Participants |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 18 | -33.68 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 24 | -33.47 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 30 | -32.07 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 36 | -35.28 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 48 | -36.26 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 60 | -37.99 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 24 | -27.20 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 36 | -28.86 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 60 | -29.70 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 18 | -23.77 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 30 | -22.40 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 48 | -22.58 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 60 | -24.95 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 48 | -18.87 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 36 | -19.17 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 30 | -16.72 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 18 | -19.16 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 24 | -19.84 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 36 | -33.99 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 24 | -35.59 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 30 | -35.92 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 60 | -37.20 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 48 | -34.77 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 18 | -27.00 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 18 | -36.01 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 48 | -45.69 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 24 | -38.27 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 30 | -36.86 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 36 | -42.20 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 60 | -43.98 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 36 | -32.92 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 30 | -34.00 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 48 | -35.72 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 60 | -34.38 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 24 | -32.93 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063 | Week 18 | -28.65 units on a scale |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | 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 | Week 18 | -3.27 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | 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 | Week 24 | -3.43 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | 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 | Week 30 | -3.17 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | 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 | Week 36 | -3.45 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | 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 | Week 48 | -3.55 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | 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 | Week 60 | -4.06 units on a scale |
| ABBV-105 60 mg/UPA Placebo | 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 | Week 24 | -2.62 units on a scale |
| ABBV-105 60 mg/UPA Placebo | 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 | Week 36 | -3.12 units on a scale |
| ABBV-105 60 mg/UPA Placebo | 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 | Week 60 | -3.21 units on a scale |
| ABBV-105 60 mg/UPA Placebo | 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 | Week 18 | -1.98 units on a scale |
| ABBV-105 60 mg/UPA Placebo | 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 | Week 30 | -2.37 units on a scale |
| ABBV-105 60 mg/UPA Placebo | 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 | Week 48 | -2.77 units on a scale |
| ABBV-105 20 mg/UPA Placebo | 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 | Week 60 | -2.55 units on a scale |
| ABBV-105 20 mg/UPA Placebo | 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 | Week 48 | -1.68 units on a scale |
| ABBV-105 20 mg/UPA Placebo | 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 | Week 36 | -1.63 units on a scale |
| ABBV-105 20 mg/UPA Placebo | 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 | Week 30 | -1.45 units on a scale |
| ABBV-105 20 mg/UPA Placebo | 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 | Week 18 | -1.93 units on a scale |
| ABBV-105 20 mg/UPA Placebo | 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 | Week 24 | -2.02 units on a scale |
| ABBV-105 5 mg/UPA Placebo | 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 | Week 36 | -3.00 units on a scale |
| ABBV-105 5 mg/UPA Placebo | 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 | Week 24 | -3.20 units on a scale |
| ABBV-105 5 mg/UPA Placebo | 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 | Week 30 | -3.30 units on a scale |
| ABBV-105 5 mg/UPA Placebo | 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 | Week 60 | -3.41 units on a scale |
| ABBV-105 5 mg/UPA Placebo | 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 | Week 48 | -3.16 units on a scale |
| ABBV-105 5 mg/UPA Placebo | 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 | Week 18 | -2.55 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | 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 | Week 18 | -3.88 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | 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 | Week 48 | -4.38 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | 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 | Week 24 | -4.02 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | 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 | Week 30 | -3.84 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | 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 | Week 36 | -4.15 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | 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 | Week 60 | -4.12 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | 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 | Week 36 | -3.77 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | 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 | Week 30 | -4.08 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | 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 | Week 48 | -3.86 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | 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 | Week 60 | -3.69 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | 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 | Week 24 | -3.61 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | 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 | Week 18 | -2.87 units on a scale |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 18 | -0.57 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 24 | -0.59 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 30 | -0.64 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 36 | -0.67 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 48 | -0.70 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 60 | -0.78 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 24 | -0.46 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 36 | -0.70 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 60 | -0.75 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 18 | -0.49 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 30 | -0.45 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 48 | -0.63 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 60 | -0.31 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 48 | -0.29 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 36 | -0.33 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 30 | -0.15 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 18 | -0.61 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 24 | -0.57 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 36 | -0.30 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 24 | -0.54 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 30 | -0.51 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 60 | -0.58 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 48 | -0.42 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 18 | -0.61 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 18 | -0.85 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 48 | -0.39 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 24 | -0.59 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 30 | -0.73 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 36 | -0.51 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 60 | -0.48 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 36 | -0.56 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 30 | -0.75 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 48 | -0.71 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 60 | -0.72 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 24 | -0.78 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063 | Week 18 | -0.47 units on a scale |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 18 | -16.04 mg/L |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 24 | -15.08 mg/L |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 30 | -16.61 mg/L |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 36 | -13.88 mg/L |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 48 | -16.41 mg/L |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 60 | -25.69 mg/L |
| ABBV-105 60 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 24 | -0.20 mg/L |
| ABBV-105 60 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 36 | -12.43 mg/L |
| ABBV-105 60 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 60 | -31.46 mg/L |
| ABBV-105 60 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 18 | 5.34 mg/L |
| ABBV-105 60 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 30 | -6.00 mg/L |
| ABBV-105 60 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 48 | -18.38 mg/L |
| ABBV-105 20 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 60 | -3.98 mg/L |
| ABBV-105 20 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 48 | -5.99 mg/L |
| ABBV-105 20 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 36 | -1.58 mg/L |
| ABBV-105 20 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 30 | -1.66 mg/L |
| ABBV-105 20 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 18 | -0.96 mg/L |
| ABBV-105 20 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 24 | -2.18 mg/L |
| ABBV-105 5 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 36 | -13.61 mg/L |
| ABBV-105 5 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 24 | -15.09 mg/L |
| ABBV-105 5 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 30 | -17.11 mg/L |
| ABBV-105 5 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 60 | -25.58 mg/L |
| ABBV-105 5 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 48 | -20.18 mg/L |
| ABBV-105 5 mg/UPA Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 18 | -14.85 mg/L |
| UPA 15 mg/ABBV-105 Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 18 | -11.48 mg/L |
| UPA 15 mg/ABBV-105 Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 48 | -7.22 mg/L |
| UPA 15 mg/ABBV-105 Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 24 | -9.48 mg/L |
| UPA 15 mg/ABBV-105 Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 30 | -9.55 mg/L |
| UPA 15 mg/ABBV-105 Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 36 | -7.76 mg/L |
| UPA 15 mg/ABBV-105 Placebo | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 60 | -3.34 mg/L |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 36 | -18.34 mg/L |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 30 | -16.22 mg/L |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 48 | -18.30 mg/L |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 60 | -12.47 mg/L |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 24 | -13.16 mg/L |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063 | Week 18 | -10.00 mg/L |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 18 | -4.27 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 24 | -4.48 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 30 | -4.36 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 36 | -4.43 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 48 | -5.47 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 60 | -4.89 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 24 | -2.64 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 36 | -3.38 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 60 | -4.50 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 18 | -2.27 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 30 | -2.23 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 48 | -3.33 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 60 | -3.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 48 | -1.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 36 | -1.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 30 | -1.20 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 18 | -2.14 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 24 | -3.29 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 36 | -4.00 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 24 | -3.70 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 30 | -4.20 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 60 | -4.40 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 48 | -4.13 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 18 | -3.40 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 18 | -5.29 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 48 | -5.38 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 24 | -4.88 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 30 | -4.53 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 36 | -5.55 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 60 | -4.80 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 36 | -3.00 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 30 | -3.13 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 48 | -3.67 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 60 | -3.00 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 24 | -3.50 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Morning Stiffness Severity From Baseline of Study M16-063 | Week 18 | -2.38 units on a scale |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 18 | -49.68 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 24 | -45.46 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 30 | -48.18 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 36 | -49.22 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 48 | -60.06 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 60 | -54.67 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 24 | -48.36 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 36 | -47.13 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 60 | -52.00 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 18 | -34.67 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 30 | -40.62 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 48 | -49.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 60 | -45.50 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 48 | -35.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 36 | -25.67 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 30 | -20.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 18 | -25.57 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 24 | -29.43 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 36 | -46.70 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 24 | -42.00 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 30 | -45.90 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 60 | -58.80 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 48 | -56.13 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 18 | -32.50 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 18 | -56.17 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 48 | -58.75 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 24 | -57.76 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 30 | -53.63 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 36 | -58.83 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 60 | -61.00 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 36 | -54.83 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 30 | -60.25 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 48 | -61.50 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 60 | -55.00 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 24 | -59.38 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063 | Week 18 | -47.88 units on a scale |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 18 | -45.18 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 24 | -48.62 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 30 | -46.18 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 36 | -51.70 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 48 | -54.24 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 60 | -56.67 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 24 | -45.93 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 36 | -48.63 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 60 | -56.00 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 18 | -34.07 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 30 | -39.69 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 48 | -44.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 60 | -54.50 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 48 | -38.67 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 36 | -31.67 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 30 | -21.40 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 18 | -28.57 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 24 | -33.29 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 36 | -46.20 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 24 | -45.20 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 30 | -45.20 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 60 | -54.60 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 48 | -53.13 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 18 | -35.70 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 18 | -56.56 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 48 | -60.75 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 24 | -62.47 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 30 | -56.31 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 36 | -61.00 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 60 | -59.80 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 36 | -53.33 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 30 | -57.75 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 48 | -56.67 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 60 | -57.00 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 24 | -58.13 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063 | Week 18 | -40.13 units on a scale |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 60 | -64.33 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 30 | -55.04 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 48 | -56.39 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 18 | -57.22 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 24 | -57.93 units on a scale |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 36 | -57.55 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 60 | -56.00 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 18 | -41.00 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 30 | -41.23 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 48 | -36.83 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 24 | -48.36 units on a scale |
| ABBV-105 60 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 36 | -53.75 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 30 | -41.80 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 60 | -65.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 24 | -39.43 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 18 | -33.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 36 | -60.00 units on a scale |
| ABBV-105 20 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 48 | -56.67 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 18 | -35.00 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 48 | -57.14 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 60 | -61.50 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 36 | -54.78 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 30 | -54.78 units on a scale |
| ABBV-105 5 mg/UPA Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 24 | -50.89 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 30 | -56.20 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 48 | -66.13 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 36 | -68.45 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 60 | -60.00 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 24 | -61.19 units on a scale |
| UPA 15 mg/ABBV-105 Placebo | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 18 | -59.06 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 60 | -56.75 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 18 | -55.13 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 24 | -62.38 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 30 | -63.50 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 36 | -65.83 units on a scale |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063 | Week 48 | -66.40 units on a scale |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 18 | -11.50 swollen joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 24 | -11.67 swollen joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 30 | -11.87 swollen joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 36 | -12.38 swollen joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 48 | -13.67 swollen joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 60 | -14.44 swollen joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 24 | -10.54 swollen joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 36 | -10.13 swollen joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 60 | -12.50 swollen joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 18 | -9.88 swollen joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 30 | -7.69 swollen joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 48 | -8.00 swollen joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 60 | -7.50 swollen joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 48 | -8.00 swollen joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 36 | -7.75 swollen joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 30 | -5.86 swollen joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 18 | -8.00 swollen joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 24 | -7.67 swollen joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 36 | -14.60 swollen joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 24 | -15.60 swollen joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 30 | -15.50 swollen joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 60 | -15.40 swollen joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 48 | -15.88 swollen joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 18 | -13.42 swollen joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 18 | -12.80 swollen joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 48 | -15.75 swollen joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 24 | -13.24 swollen joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 30 | -13.44 swollen joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 36 | -14.25 swollen joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 60 | -13.00 swollen joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 36 | -10.50 swollen joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 30 | -10.75 swollen joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 48 | -10.67 swollen joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 60 | -11.25 swollen joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 24 | -10.38 swollen joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063 | Week 18 | -9.78 swollen joint counts |
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.
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 18 | -17.29 tender joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 24 | -17.93 tender joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 30 | -16.30 tender joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 36 | -16.42 tender joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 48 | -17.33 tender joint counts |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 60 | -19.78 tender joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 24 | -15.77 tender joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 36 | -15.25 tender joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 60 | -19.00 tender joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 18 | -12.69 tender joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 30 | -9.54 tender joint counts |
| ABBV-105 60 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 48 | -12.33 tender joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 60 | -11.50 tender joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 48 | -5.50 tender joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 36 | -8.00 tender joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 30 | -4.57 tender joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 18 | -9.82 tender joint counts |
| ABBV-105 20 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 24 | -8.11 tender joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 36 | -18.40 tender joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 24 | -20.20 tender joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 30 | -19.80 tender joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 60 | -20.20 tender joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 48 | -18.88 tender joint counts |
| ABBV-105 5 mg/UPA Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 18 | -14.17 tender joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 18 | -19.75 tender joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 48 | -28.88 tender joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 24 | -20.76 tender joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 30 | -20.50 tender joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 36 | -24.92 tender joint counts |
| UPA 15 mg/ABBV-105 Placebo | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 60 | -26.20 tender joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 36 | -14.83 tender joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 30 | -14.88 tender joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 48 | -15.00 tender joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 60 | -15.50 tender joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 24 | -14.25 tender joint counts |
| Placebo in M16-063/ABBV-599 in M16-763 | Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063 | Week 18 | -10.67 tender joint counts |
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.
Time frame: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 17.4 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 29.6 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 26.1 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 36.4 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 44.4 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 33.3 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 23.1 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 25.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 50.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 13.3 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 30.8 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 33.3 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 50.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 25.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 14.3 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 11.1 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 11.1 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 10.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 10.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 30.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 20.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 12.5 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 12.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 55.6 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 50.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 58.8 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 43.8 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 41.7 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 60.0 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 50.0 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 87.5 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 50.0 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 50.0 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 25.0 percentage of participants |
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.
Time frame: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 56.5 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 66.7 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 77.8 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 70.4 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 72.2 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 65.2 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 50.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 53.8 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 62.5 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 66.7 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 20.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 46.2 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 11.1 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 33.3 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 50.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 40.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 20.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 30.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 20.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 25.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 87.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 75.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 70.6 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 60.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 62.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 77.8 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 75.0 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 66.7 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 71.4 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 83.3 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 50.0 percentage of participants |
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.
Time frame: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 82.6 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 88.9 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 78.3 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 86.4 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 100 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 77.8 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 40.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 76.9 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 87.5 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 66.7 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 69.2 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 50.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 75.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 44.4 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 55.6 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 42.9 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 75.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 100 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 80.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 62.5 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 80.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 70.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 80.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 50.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 77.8 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 81.3 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 87.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 88.2 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 80.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 83.3 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 18 | 62.5 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 24 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 36 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 30 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 48 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria | Week 60 | 75.0 percentage of participants |
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.
Time frame: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 100 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 78.3 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 78.3 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 87.5 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 77.8 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 77.8 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 50.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 26.7 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 53.8 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 87.5 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 66.7 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 76.9 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 44.4 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 28.6 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 50.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 25.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 100 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 44.4 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 20.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 37.5 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 60.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 50.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 60.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 40.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 88.2 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 100 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 77.8 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 87.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 91.7 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 87.5 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 60 | 75.0 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 18 | 62.5 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 24 | 85.7 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 30 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 36 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 48 | 100 percentage of participants |
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: 1. ≥ 20% improvement in 68-tender joint count from Baseline of Study M16-063 2. ≥ 20% improvement in 66-swollen joint count from Baseline of Study M16-063 and 3. ≥ 20% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 18 | 90.9 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 60 | 88.9 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 48 | 94.1 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 36 | 87.0 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 30 | 86.4 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 24 | 96.2 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 18 | 80.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 24 | 92.9 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 30 | 69.2 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 36 | 87.5 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 48 | 83.3 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 60 | 100 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 30 | 50.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 24 | 85.7 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 36 | 66.7 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 18 | 57.1 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 48 | 66.7 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 60 | 100 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 30 | 80.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 24 | 77.8 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 60 | 75.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 36 | 88.9 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 18 | 66.7 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 48 | 85.7 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 48 | 87.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 60 | 100 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 24 | 93.8 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 30 | 87.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 36 | 91.7 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 18 | 88.2 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 24 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 30 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 36 | 83.3 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 48 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 60 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 18 | 75.0 percentage of participants |
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: 1. ≥ 50% improvement in 68-tender joint count from Baseline of Study M16-063 2. ≥ 50% improvement in 66-swollen joint count from Baseline of Study M16-063 and 3. ≥ 50% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 18 | 68.2 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 24 | 76.9 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 30 | 63.6 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 36 | 82.6 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 48 | 82.4 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 60 | 88.9 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 24 | 64.3 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 36 | 62.5 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 60 | 50.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 18 | 46.7 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 30 | 61.5 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 48 | 66.7 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 60 | 100 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 48 | 66.7 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 36 | 33.3 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 30 | 16.7 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 18 | 40.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 24 | 42.9 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 36 | 66.7 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 24 | 66.7 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 30 | 60.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 60 | 75.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 48 | 71.4 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 18 | 40.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 18 | 70.6 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 48 | 87.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 24 | 87.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 30 | 87.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 36 | 75.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 60 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 36 | 66.7 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 30 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 48 | 83.3 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 60 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 24 | 100 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response | Week 18 | 62.5 percentage of participants |
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: 1. ≥ 70% improvement in 68-tender joint count from Baseline of Study M16-063 2. ≥ 70% improvement in 66-swollen joint count from Baseline of Study M16-063 and 3. ≥ 70% improvement in at least 3 of the 5 following parameters from Baseline of Study M16-063: * Patient's Assessment of Pain (Visual Analog Scale \[VAS\]) * Patient's Global Assessment of Disease Activity (PtGA) * Physician's Global Assessment of Disease Activity (PhGA) * Health Assessment Questionnaire Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Time frame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 48 | 58.8 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 18 | 47.8 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 36 | 78.3 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 30 | 63.6 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 24 | 57.7 percentage of participants |
| ABBV-599 in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 60 | 88.9 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 24 | 42.9 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 60 | 50.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 18 | 33.3 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 48 | 50.0 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 30 | 46.2 percentage of participants |
| ABBV-105 60 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 36 | 50.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 30 | 14.3 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 24 | 12.5 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 18 | 20.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 60 | 50.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 36 | 25.0 percentage of participants |
| ABBV-105 20 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 48 | 25.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 36 | 44.4 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 18 | 25.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 24 | 55.6 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 30 | 60.0 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 48 | 42.9 percentage of participants |
| ABBV-105 5 mg/UPA Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 60 | 25.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 30 | 68.8 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 36 | 75.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 18 | 55.6 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 24 | 62.5 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 60 | 60.0 percentage of participants |
| UPA 15 mg/ABBV-105 Placebo | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 48 | 75.0 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 48 | 83.3 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 30 | 87.5 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 60 | 75.0 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 36 | 66.7 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 18 | 37.5 percentage of participants |
| Placebo in M16-063/ABBV-599 in M16-763 | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response | Week 24 | 87.5 percentage of participants |