A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
NCT02349451 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2017-08-04
Summary
This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants with active PsA who are inadequately responding to MTX treatment.
Conditions
Interventions
- BIOLOGICAL
- BIOLOGICAL
-
ABT-122
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Paul Peloso, MD · AbbVie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-04-28
- Primary Completion
- 2016-07-04
- Completion
- 2016-07-04
More Related Trials
-
Methotrexate-Inadequate Response Study
NCT00559585 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate
NCT02629159 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Phase IIIB Subcutaneous Abatacept Monotherapy Study
NCT00547521 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
NCT00409838 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
NCT00124982 ·Status: COMPLETED ·Phase: PHASE3
-
Methotrexate - Inadequate Response Device Sub-Study
NCT01173120 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
NCT02706951 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
NCT00646386 ·Status: COMPLETED ·Phase: PHASE2
-
Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis
NCT00649545 ·Status: APPROVED_FOR_MARKETING
-
Remission and Joint Damage Progression in Early Rheumatoid Arthritis
NCT00122382 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy
NCT00646178 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)
NCT02814175 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
NCT01853033 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)
NCT00254293 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Methotrexate-Inadequate Response Autoinjector Device Sub Study
NCT01844895 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Adalimumab in Patients With Active Psoriatic Arthritis (PsA)
NCT00235885 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
NCT02504268 ·Status: COMPLETED ·Phase: PHASE3
-
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
NCT01373151 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
NCT00195702 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis
NCT01999192 ·Status: TERMINATED ·Phase: PHASE2
-
Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)
NCT01088321 ·Status: COMPLETED
-
A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
NCT03086343 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494
NCT01741493 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients
NCT01001832 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis
NCT04713072 ·Status: COMPLETED ·Phase: PHASE2