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Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

ABT-122

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Tolerability, Methotrexate, Safety

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Subjects who have completed the preceding Study M12-963 (ABT-122) randomized controlled study and have not developed any discontinuation criteria, as defined in Study M12-963.

If female, subject must meet one of the following criteria:
1. Postmenopausal (defined as no menses for at least 1 year).
2. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
3. Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug.
Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.

Exclusion Criteria: - Pregnant or breastfeeding female.

Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
Current enrollment in another investigational study; with the exception of Study M12-963, which is required.
Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABT-122 120 mg EOW

Arm Description

All subjects receive open-label ABT-122 120 mg EOW subcutaneously, with the first dose administered at the last visit of Study M12-963 randomized controlled trial.

Outcomes

Primary Outcome Measures

American College of Rheumatology (ACR) 20 Response Rate at Week 2

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

ACR20 Response Rate at Week 4

Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

ACR20 Response Rate at Week 6

ACR20 Response Rate at Week 8

ACR20 Response Rate at Week 12

ACR20 Response Rate at Week 16

ACR20 Response Rate at Week 20

ACR20 Response Rate at Week 24

ACR20 Response Rate at Week 28

ACR20 Response Rate at Week 32

ACR20 Response Rate at Week 36

ACR50 Response Rate at Week 2

Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

ACR50 Response Rate at Week 4

ACR50 Response Rate at Week 6

ACR50 Response Rate at Week 8

ACR50 Response Rate at Week 12

ACR50 Response Rate at Week 16

ACR50 Response Rate at Week 20

ACR50 Response Rate at Week 24

ACR50 Response Rate at Week 28

ACR50 Response Rate at Week 32

ACR50 Response Rate at Week 36

ACR70 Response Rate at Week 2

Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

ACR70 Response Rate at Week 4

ACR70 Response Rate at Week 6

ACR70 Response Rate at Week 8

ACR70 Response Rate at Week 12

ACR70 Response Rate at Week 16

ACR70 Response Rate at Week 20

ACR70 Response Rate at Week 24

ACR70 Response Rate at Week 28

ACR70 Response Rate at Week 32

ACR70 Response Rate at Week 36

Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. An 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Secondary Outcome Measures

Change From Baseline In Tender Joint Count (TJC68) at Week 2

At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in TJC68 at Week 4

Change From Baseline in TJC68 at Week 6

Change From Baseline in TJC68 at Week 8

Change From Baseline in TJC68 at Week 12

Change From Baseline in TJC68 at Week 16

Change From Baseline in TJC68 at Week 20

Change From Baseline in TJC68 at Week 24

Change From Baseline in TJC68 at Week 28

Change From Baseline in TJC68 at Week 32

Change From Baseline in TJC68 at Week 36

Change From Baseline in Swollen Joint Count (SJC66) at Week 2

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in SJC66 at Week 4

Change From Baseline in SJC66 at Week 6

Change From Baseline in SJC66 at Week 8

Change From Baseline in SJC66 at Week 12

Change From Baseline in SJC66 at Week 16

Change From Baseline in SJC66 at Week 20

Change From Baseline in SJC66 at Week 24

Change From Baseline in SJC66 at Week 28

Change From Baseline in SJC66 at Week 32

Change From Baseline in SJC66 at Week 36

Change From Baseline in Patient's Assessment of Pain at Week 2

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in Patient's Assessment of Pain at Week 4

Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in Patient's Assessment of Pain at Week 6

Change From Baseline in Patient's Assessment of Pain at Week 8

Change From Baseline in Patient's Assessment of Pain at Week 12

Change From Baseline in Patient's Assessment of Pain at Week 16

Change From Baseline in Patient's Assessment of Pain at Week 20

Change From Baseline in Patient's Assessment of Pain at Week 24

Change From Baseline in Patient's Assessment of Pain at Week 28

Change From Baseline in Patient's Assessment of Pain at Week 32

Change From Baseline in Patient's Assessment of Pain at Week 36

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2

Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2

The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2

HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in HAQ-DI at Week 4

Change From Baseline in HAQ-DI at Week 6

Change From Baseline in HAQ-DI at Week 8

Change From Baseline in HAQ-DI at Week 12

Change From Baseline in HAQ-DI at Week 16

Change From Baseline in HAQ-DI at Week 20

Change From Baseline in HAQ-DI at Week 24

Change From Baseline in HAQ-DI at Week 28

Change From Baseline in HAQ-DI at Week 32

Change From Baseline in HAQ-DI at Week 36

Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 4

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 6

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 8

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 12

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 16

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 20

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 24

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 28

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 32

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in hsCRP at Week 36

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in DAS28 (hsCRP) at Week 4

Change From Baseline in DAS28 (hsCRP) at Week 6

Change From Baseline in DAS28 (hsCRP) at Week 8

Change From Baseline in DAS28 (hsCRP) at Week 12

Change From Baseline in DAS28 (hsCRP) at Week 16

Change From Baseline in DAS28 (hsCRP) at Week 20

Change From Baseline in DAS28 (hsCRP) at Week 24

Change From Baseline in DAS28 (hsCRP) at Week 28

Change From Baseline in DAS28 (hsCRP) at Week 32

Change From Baseline in DAS28 (hsCRP) at Week 36

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2

CDAI is a composite index for assessing disease activity based on the summation of the counts of Tender Joint Count 28 (TJC28) and Swollen Joint Count 28 (SJC28), 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. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in CDAI at Week 4

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, 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. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Change From Baseline in CDAI at Week 6

Change From Baseline in CDAI at Week 8

Change From Baseline in CDAI at Week 12

Change From Baseline in CDAI at Week 16

Change From Baseline in CDAI at Week 20

Change From Baseline in CDAI at Week 24

Change From Baseline in CDAI at Week 28

Change From Baseline in CDAI at Week 32

Change From Baseline in CDAI at Week 36

Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2

Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36

CR Response Rate Per DAS28 (hsCRP) at Week 2

Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

CR Response Rate Per DAS28 (hsCRP) at Week 4

CR Response Rate Per DAS28 (hsCRP) at Week 6

CR Response Rate Per DAS28 (hsCRP) at Week 8

CR Response Rate Per DAS28 (hsCRP) at Week 12

CR Response Rate Per DAS28 (hsCRP) at Week 16

CR Response Rate Per DAS28 (hsCRP) at Week 20

CR Response Rate Per DAS28 (hsCRP) at Week 24

CR Response Rate Per DAS28 (hsCRP) at Week 28

CR Response Rate Per DAS28 (hsCRP) at Week 32

CR Response Rate Per DAS28 (hsCRP) at Week 36

LDA or CR Response Rate Per CDAI at Week 2

Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, 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. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

LDA or CR Response Rate Per CDAI at Week 4

LDA or CR Response Rate Per CDAI at Week 6

LDA or CR Response Rate Per CDAI at Week 8

LDA or CR Response Rate Per CDAI at Week 12

LDA or CR Response Rate Per CDAI at Week 16

LDA or CR Response Rate Per CDAI at Week 20

LDA or CR Response Rate Per CDAI at Week 24

LDA or CR Response Rate Per CDAI at Week 28

LDA or CR Response Rate Per CDAI at Week 32

LDA or CR Response Rate Per CDAI at Week 36

CR Response Rate Per CDAI Criteria at Week 2

Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, 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. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

CR Response Rate Per CDAI Criteria at Week 4

CR Response Rate Per CDAI Criteria at Week 6

CR Response Rate Per CDAI Criteria at Week 8

CR Response Rate Per CDAI Criteria at Week 12

CR Response Rate Per CDAI Criteria at Week 16

CR Response Rate Per CDAI Criteria at Week 20

CR Response Rate Per CDAI Criteria at Week 24

Percentage of participants achieving CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, 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. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.

CR Response Rate Per CDAI Criteria at Week 28

CR Response Rate Per CDAI Criteria at Week 32

CR Response Rate Per CDAI Criteria at Week 36

Full Information

NCT ID

NCT02433340

First Posted

April 2, 2015

Last Updated

June 23, 2017

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02433340

Brief Title

Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

Official Title

Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab 40 mg EOW given on background methotrexate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Tolerability, Methotrexate, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

158 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABT-122 120 mg EOW

Arm Type

Experimental

Arm Description

All subjects receive open-label ABT-122 120 mg EOW subcutaneously, with the first dose administered at the last visit of Study M12-963 randomized controlled trial.

Intervention Type

Drug

Intervention Name(s)

ABT-122

Other Intervention Name(s)

Remtolumab

Primary Outcome Measure Information:

Title

American College of Rheumatology (ACR) 20 Response Rate at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

ACR20 Response Rate at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

ACR20 Response Rate at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

ACR20 Response Rate at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

ACR20 Response Rate at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

ACR20 Response Rate at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

ACR20 Response Rate at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

ACR20 Response Rate at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

ACR20 Response Rate at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

ACR20 Response Rate at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

ACR20 Response Rate at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

ACR50 Response Rate at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

ACR50 Response Rate at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

ACR50 Response Rate at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

ACR50 Response Rate at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

ACR50 Response Rate at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

ACR50 Response Rate at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

ACR50 Response Rate at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

ACR50 Response Rate at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

ACR50 Response Rate at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

ACR50 Response Rate at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

ACR50 Response Rate at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

ACR70 Response Rate at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

ACR70 Response Rate at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

ACR70 Response Rate at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

ACR70 Response Rate at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

ACR70 Response Rate at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

ACR70 Response Rate at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

ACR70 Response Rate at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

ACR70 Response Rate at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

ACR70 Response Rate at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

ACR70 Response Rate at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

ACR70 Response Rate at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths

Description

Time Frame

from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks)

Secondary Outcome Measure Information:

Title

Change From Baseline In Tender Joint Count (TJC68) at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

Change From Baseline in TJC68 at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

Change From Baseline in TJC68 at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

Change From Baseline in TJC68 at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

Change From Baseline in TJC68 at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

Change From Baseline in TJC68 at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

Change From Baseline in TJC68 at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

Change From Baseline in TJC68 at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

Change From Baseline in TJC68 at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

Change From Baseline in TJC68 at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

Change From Baseline in TJC68 at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Change From Baseline in Swollen Joint Count (SJC66) at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

Change From Baseline in SJC66 at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

Change From Baseline in SJC66 at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

Change From Baseline in SJC66 at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

Change From Baseline in SJC66 at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

Change From Baseline in SJC66 at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

Change From Baseline in SJC66 at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

Change From Baseline in SJC66 at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

Change From Baseline in SJC66 at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

Change From Baseline in SJC66 at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

Change From Baseline in SJC66 at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Change From Baseline in Patient's Assessment of Pain at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

Change From Baseline in Patient's Assessment of Pain at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

Change From Baseline in Patient's Assessment of Pain at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

Change From Baseline in Patient's Assessment of Pain at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

Change From Baseline in Patient's Assessment of Pain at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

Change From Baseline in Patient's Assessment of Pain at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

Change From Baseline in Patient's Assessment of Pain at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

Change From Baseline in Patient's Assessment of Pain at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

Change From Baseline in Patient's Assessment of Pain at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

Change From Baseline in Patient's Assessment of Pain at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

Change From Baseline in Patient's Assessment of Pain at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

Change From Baseline in HAQ-DI at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

Change From Baseline in HAQ-DI at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

Change From Baseline in HAQ-DI at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

Change From Baseline in HAQ-DI at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

Change From Baseline in HAQ-DI at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

Change From Baseline in HAQ-DI at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

Change From Baseline in HAQ-DI at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

Change From Baseline in HAQ-DI at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

Change From Baseline in HAQ-DI at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

Change From Baseline in HAQ-DI at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 2 of Study M12-963

Title

Change From Baseline in hsCRP at Week 4

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 4 of Study M12-963

Title

Change From Baseline in hsCRP at Week 6

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 6 of Study M12-963

Title

Change From Baseline in hsCRP at Week 8

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 8 of Study M12-963

Title

Change From Baseline in hsCRP at Week 12

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

Change From Baseline in hsCRP at Week 16

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

Change From Baseline in hsCRP at Week 20

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

Change From Baseline in hsCRP at Week 24

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

Change From Baseline in hsCRP at Week 28

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

Change From Baseline in hsCRP at Week 32

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

Change From Baseline in hsCRP at Week 36

Description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

Change From Baseline in DAS28 (hsCRP) at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

Change From Baseline in DAS28 (hsCRP) at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

Change From Baseline in DAS28 (hsCRP) at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

Change From Baseline in DAS28 (hsCRP) at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

Change From Baseline in DAS28 (hsCRP) at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

Change From Baseline in DAS28 (hsCRP) at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

Change From Baseline in DAS28 (hsCRP) at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

Change From Baseline in DAS28 (hsCRP) at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

Change From Baseline in DAS28 (hsCRP) at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

Change From Baseline in DAS28 (hsCRP) at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

Change From Baseline in CDAI at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

Change From Baseline in CDAI at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

Change From Baseline in CDAI at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

Change From Baseline in CDAI at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

Change From Baseline in CDAI at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

Change From Baseline in CDAI at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

Change From Baseline in CDAI at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

Change From Baseline in CDAI at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

Change From Baseline in CDAI at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

Change From Baseline in CDAI at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

CR Response Rate Per DAS28 (hsCRP) at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

CR Response Rate Per DAS28 (hsCRP) at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

CR Response Rate Per DAS28 (hsCRP) at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

CR Response Rate Per DAS28 (hsCRP) at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

CR Response Rate Per DAS28 (hsCRP) at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

CR Response Rate Per DAS28 (hsCRP) at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

CR Response Rate Per DAS28 (hsCRP) at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

CR Response Rate Per DAS28 (hsCRP) at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

CR Response Rate Per DAS28 (hsCRP) at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

CR Response Rate Per DAS28 (hsCRP) at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

CR Response Rate Per DAS28 (hsCRP) at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

LDA or CR Response Rate Per CDAI at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

LDA or CR Response Rate Per CDAI at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

LDA or CR Response Rate Per CDAI at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

LDA or CR Response Rate Per CDAI at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

LDA or CR Response Rate Per CDAI at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

LDA or CR Response Rate Per CDAI at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

LDA or CR Response Rate Per CDAI at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

LDA or CR Response Rate Per CDAI at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

LDA or CR Response Rate Per CDAI at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

LDA or CR Response Rate Per CDAI at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

LDA or CR Response Rate Per CDAI at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

Title

CR Response Rate Per CDAI Criteria at Week 2

Description

Time Frame

Week 2 of Study M12-963

Title

CR Response Rate Per CDAI Criteria at Week 4

Description

Time Frame

Week 4 of Study M12-963

Title

CR Response Rate Per CDAI Criteria at Week 6

Description

Time Frame

Week 6 of Study M12-963

Title

CR Response Rate Per CDAI Criteria at Week 8

Description

Time Frame

Week 8 of Study M12-963

Title

CR Response Rate Per CDAI Criteria at Week 12

Description

Time Frame

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Title

CR Response Rate Per CDAI Criteria at Week 16

Description

Time Frame

Week 16 (Week 4 of Study M12-965)

Title

CR Response Rate Per CDAI Criteria at Week 20

Description

Time Frame

Week 20 (Week 8 of Study M12-965)

Title

CR Response Rate Per CDAI Criteria at Week 24

Description

Time Frame

Week 24 (Week 12 of Study M12-965)

Title

CR Response Rate Per CDAI Criteria at Week 28

Description

Time Frame

Week 28 (Week 16 of Study M12-965)

Title

CR Response Rate Per CDAI Criteria at Week 32

Description

Time Frame

Week 32 (Week 20 of Study M12-965)

Title

CR Response Rate Per CDAI Criteria at Week 36

Description

Time Frame

Week 36 (Week 24 of Study M12-965)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Subjects who have completed the preceding Study M12-963 (ABT-122) randomized controlled study and have not developed any discontinuation criteria, as defined in Study M12-963. If female, subject must meet one of the following criteria: Postmenopausal (defined as no menses for at least 1 year). Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug. Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug. Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed. Exclusion Criteria: - Pregnant or breastfeeding female. Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days. Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug. Current enrollment in another investigational study; with the exception of Study M12-963, which is required. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Peloso, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

30376130

Citation

Khatri A, Klunder B, Peloso PM, Othman AA. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):352-360. doi: 10.1093/rheumatology/key312.

Results Reference

derived

PubMed Identifier

30032191

Citation

Genovese MC, Weinblatt ME, Mease PJ, Aelion JA, Peloso PM, Chen K, Li Y, Liu J, Othman AA, Khatri A, Mansikka HT, Leszczynski P. Dual inhibition of tumour necrosis factor and interleukin-17A with ABT-122: open-label long-term extension studies in rheumatoid arthritis or psoriatic arthritis. Rheumatology (Oxford). 2018 Nov 1;57(11):1972-1981. doi: 10.1093/rheumatology/key173.

Results Reference

derived

Learn more about this trial

Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

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