Clinical trial NCT02433340: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Tolerability
Methotrexate
Safety
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-05-05
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: American College of Rheumatology (ACR) 20 Response Rate at Week 2
timeFrame: Week 2 of Study M12-963
measure: ACR20 Response Rate at Week 4
timeFrame: Week 4 of Study M12-963
measure: ACR20 Response Rate at Week 6
timeFrame: Week 6 of Study M12-963
measure: ACR20 Response Rate at Week 8
timeFrame: Week 8 of Study M12-963
measure: ACR20 Response Rate at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: ACR20 Response Rate at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: ACR20 Response Rate at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: ACR20 Response Rate at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: ACR20 Response Rate at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: ACR20 Response Rate at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: ACR20 Response Rate at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: ACR50 Response Rate at Week 2
timeFrame: Week 2 of Study M12-963
measure: ACR50 Response Rate at Week 4
timeFrame: Week 4 of Study M12-963
measure: ACR50 Response Rate at Week 6
timeFrame: Week 6 of Study M12-963
measure: ACR50 Response Rate at Week 8
timeFrame: Week 8 of Study M12-963
measure: ACR50 Response Rate at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: ACR50 Response Rate at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: ACR50 Response Rate at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: ACR50 Response Rate at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: ACR50 Response Rate at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: ACR50 Response Rate at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: ACR50 Response Rate at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: ACR70 Response Rate at Week 2
timeFrame: Week 2 of Study M12-963
measure: ACR70 Response Rate at Week 4
timeFrame: Week 4 of Study M12-963
measure: ACR70 Response Rate at Week 6
timeFrame: Week 6 of Study M12-963
measure: ACR70 Response Rate at Week 8
timeFrame: Week 8 of Study M12-963
measure: ACR70 Response Rate at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: ACR70 Response Rate at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: ACR70 Response Rate at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: ACR70 Response Rate at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: ACR70 Response Rate at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: ACR70 Response Rate at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: ACR70 Response Rate at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths
timeFrame: 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 outcomes:
measure: Change From Baseline In Tender Joint Count (TJC68) at Week 2
timeFrame: Week 2 of Study M12-963
measure: Change From Baseline in TJC68 at Week 4
timeFrame: Week 4 of Study M12-963
measure: Change From Baseline in TJC68 at Week 6
timeFrame: Week 6 of Study M12-963
measure: Change From Baseline in TJC68 at Week 8
timeFrame: Week 8 of Study M12-963
measure: Change From Baseline in TJC68 at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: Change From Baseline in TJC68 at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: Change From Baseline in TJC68 at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: Change From Baseline in TJC68 at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: Change From Baseline in TJC68 at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: Change From Baseline in TJC68 at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: Change From Baseline in TJC68 at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Change From Baseline in Swollen Joint Count (SJC66) at Week 2
timeFrame: Week 2 of Study M12-963
measure: Change From Baseline in SJC66 at Week 4
timeFrame: Week 4 of Study M12-963
measure: Change From Baseline in SJC66 at Week 6
timeFrame: Week 6 of Study M12-963
measure: Change From Baseline in SJC66 at Week 8
timeFrame: Week 8 of Study M12-963
measure: Change From Baseline in SJC66 at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: Change From Baseline in SJC66 at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: Change From Baseline in SJC66 at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: Change From Baseline in SJC66 at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: Change From Baseline in SJC66 at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: Change From Baseline in SJC66 at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: Change From Baseline in SJC66 at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Change From Baseline in Patient's Assessment of Pain at Week 2
timeFrame: Week 2 of Study M12-963
measure: Change From Baseline in Patient's Assessment of Pain at Week 4
timeFrame: Week 4 of Study M12-963
measure: Change From Baseline in Patient's Assessment of Pain at Week 6
timeFrame: Week 6 of Study M12-963
measure: Change From Baseline in Patient's Assessment of Pain at Week 8
timeFrame: Week 8 of Study M12-963
measure: Change From Baseline in Patient's Assessment of Pain at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: Change From Baseline in Patient's Assessment of Pain at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: Change From Baseline in Patient's Assessment of Pain at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: Change From Baseline in Patient's Assessment of Pain at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: Change From Baseline in Patient's Assessment of Pain at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: Change From Baseline in Patient's Assessment of Pain at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: Change From Baseline in Patient's Assessment of Pain at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2
timeFrame: Week 2 of Study M12-963
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4
timeFrame: Week 4 of Study M12-963
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6
timeFrame: Week 6 of Study M12-963
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8
timeFrame: Week 8 of Study M12-963
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2
timeFrame: Week 2 of Study M12-963
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4
timeFrame: Week 4 of Study M12-963
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6
timeFrame: Week 6 of Study M12-963
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8
timeFrame: Week 8 of Study M12-963
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2
timeFrame: Week 2 of Study M12-963
measure: Change From Baseline in HAQ-DI at Week 4
timeFrame: Week 4 of Study M12-963
measure: Change From Baseline in HAQ-DI at Week 6
timeFrame: Week 6 of Study M12-963
measure: Change From Baseline in HAQ-DI at Week 8
timeFrame: Week 8 of Study M12-963
measure: Change From Baseline in HAQ-DI at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: Change From Baseline in HAQ-DI at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: Change From Baseline in HAQ-DI at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: Change From Baseline in HAQ-DI at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: Change From Baseline in HAQ-DI at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: Change From Baseline in HAQ-DI at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: Change From Baseline in HAQ-DI at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2
timeFrame: Week 2 of Study M12-963
measure: Change From Baseline in hsCRP at Week 4
timeFrame: Week 4 of Study M12-963
measure: Change From Baseline in hsCRP at Week 6
timeFrame: Week 6 of Study M12-963
measure: Change From Baseline in hsCRP at Week 8
timeFrame: Week 8 of Study M12-963
measure: Change From Baseline in hsCRP at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: Change From Baseline in hsCRP at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: Change From Baseline in hsCRP at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: Change From Baseline in hsCRP at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: Change From Baseline in hsCRP at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: Change From Baseline in hsCRP at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: Change From Baseline in hsCRP at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2
timeFrame: Week 2 of Study M12-963
measure: Change From Baseline in DAS28 (hsCRP) at Week 4
timeFrame: Week 4 of Study M12-963
measure: Change From Baseline in DAS28 (hsCRP) at Week 6
timeFrame: Week 6 of Study M12-963
measure: Change From Baseline in DAS28 (hsCRP) at Week 8
timeFrame: Week 8 of Study M12-963
measure: Change From Baseline in DAS28 (hsCRP) at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: Change From Baseline in DAS28 (hsCRP) at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: Change From Baseline in DAS28 (hsCRP) at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: Change From Baseline in DAS28 (hsCRP) at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: Change From Baseline in DAS28 (hsCRP) at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: Change From Baseline in DAS28 (hsCRP) at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: Change From Baseline in DAS28 (hsCRP) at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2
timeFrame: Week 2 of Study M12-963
measure: Change From Baseline in CDAI at Week 4
timeFrame: Week 4 of Study M12-963
measure: Change From Baseline in CDAI at Week 6
timeFrame: Week 6 of Study M12-963
measure: Change From Baseline in CDAI at Week 8
timeFrame: Week 8 of Study M12-963
measure: Change From Baseline in CDAI at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: Change From Baseline in CDAI at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: Change From Baseline in CDAI at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: Change From Baseline in CDAI at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: Change From Baseline in CDAI at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: Change From Baseline in CDAI at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: Change From Baseline in CDAI at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2
timeFrame: Week 2 of Study M12-963
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4
timeFrame: Week 4 of Study M12-963
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6
timeFrame: Week 6 of Study M12-963
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8
timeFrame: Week 8 of Study M12-963
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: CR Response Rate Per DAS28 (hsCRP) at Week 2
timeFrame: Week 2 of Study M12-963
measure: CR Response Rate Per DAS28 (hsCRP) at Week 4
timeFrame: Week 4 of Study M12-963
measure: CR Response Rate Per DAS28 (hsCRP) at Week 6
timeFrame: Week 6 of Study M12-963
measure: CR Response Rate Per DAS28 (hsCRP) at Week 8
timeFrame: Week 8 of Study M12-963
measure: CR Response Rate Per DAS28 (hsCRP) at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: CR Response Rate Per DAS28 (hsCRP) at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: CR Response Rate Per DAS28 (hsCRP) at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: CR Response Rate Per DAS28 (hsCRP) at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: CR Response Rate Per DAS28 (hsCRP) at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: CR Response Rate Per DAS28 (hsCRP) at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: CR Response Rate Per DAS28 (hsCRP) at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: LDA or CR Response Rate Per CDAI at Week 2
timeFrame: Week 2 of Study M12-963
measure: LDA or CR Response Rate Per CDAI at Week 4
timeFrame: Week 4 of Study M12-963
measure: LDA or CR Response Rate Per CDAI at Week 6
timeFrame: Week 6 of Study M12-963
measure: LDA or CR Response Rate Per CDAI at Week 8
timeFrame: Week 8 of Study M12-963
measure: LDA or CR Response Rate Per CDAI at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: LDA or CR Response Rate Per CDAI at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: LDA or CR Response Rate Per CDAI at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: LDA or CR Response Rate Per CDAI at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: LDA or CR Response Rate Per CDAI at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: LDA or CR Response Rate Per CDAI at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: LDA or CR Response Rate Per CDAI at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
measure: CR Response Rate Per CDAI Criteria at Week 2
timeFrame: Week 2 of Study M12-963
measure: CR Response Rate Per CDAI Criteria at Week 4
timeFrame: Week 4 of Study M12-963
measure: CR Response Rate Per CDAI Criteria at Week 6
timeFrame: Week 6 of Study M12-963
measure: CR Response Rate Per CDAI Criteria at Week 8
timeFrame: Week 8 of Study M12-963
measure: CR Response Rate Per CDAI Criteria at Week 12
timeFrame: Week 12 of Study M12-963 (considered Week 0 of Study M12-965)
measure: CR Response Rate Per CDAI Criteria at Week 16
timeFrame: Week 16 (Week 4 of Study M12-965)
measure: CR Response Rate Per CDAI Criteria at Week 20
timeFrame: Week 20 (Week 8 of Study M12-965)
measure: CR Response Rate Per CDAI Criteria at Week 24
timeFrame: Week 24 (Week 12 of Study M12-965)
measure: CR Response Rate Per CDAI Criteria at Week 28
timeFrame: Week 28 (Week 16 of Study M12-965)
measure: CR Response Rate Per CDAI Criteria at Week 32
timeFrame: Week 32 (Week 20 of Study M12-965)
measure: CR Response Rate Per CDAI Criteria at Week 36
timeFrame: Week 36 (Week 24 of Study M12-965)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Paul Peloso, MD
role: STUDY_DIRECTOR
References:
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.
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.