Phase 2
Completed N=276
A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy
Source: ClinicalTrials.gov NCT01960855 ↗Enrolled (actual)
276
Serious AEs
2.2%
Results posted
Jun 2018
Primary outcomePrimary: Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 — 19; 30; 33; 40 Participants — p== 0.033
Summary
The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 |
19; 30; 33; 40; 39 | = 0.033 sig |
| SECONDARY Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12 |
9; 13; 20; 24; 22 | = 0.364 |
| SECONDARY Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12 |
2; 7; 14; 12; 12 | = 0.093 |
| SECONDARY Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) Based on (DAS28) at Week 12 |
14; 18; 20; 29; 25 | = 0.366 |
| SECONDARY Number of Subjects Achieving CR Based on DAS28 at Week 12 |
7; 13; 14; 18; 17 | = 0.126 |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
- Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
- Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
- Have active RA as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) antibody.
Exclusion Criteria
- Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
- Pregnant or breastfeeding female
- Ongoing or active infection.
Data sourced from ClinicalTrials.gov (NCT01960855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.