Clinical Trial Details

Overview

Research Study Summary

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Purpose

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease of unknown etiology. The hallmark feature of RA is an inflammatory process manifested by persistent symmetric polyarthritis of synovial joints which can ultimately lead to bone erosions, deformity, and disability. Early therapy with disease-modifying anti-rheumatic drugs (DMARDs) is the standard of care. Despite major progress in the treatment of RA, there still remains a large unmet medical need and novel therapies are needed to complement the available interventions to address this unmet need.

To Learn more

CW ID: 216048
Date Last Changed: June 14, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Abbvie
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • Diagnosis of RA for ≥ 3 months who also fulfill either the 1987-revised ACR classification criteria
  • or the 2010 ACR/EULAR classification criteria for RA.
  • Subjects have been treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity.
  • Subjects have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug.
Exclusion Criteria:
  • Prior exposure to any Janus kinase (JAK) inhibitor.
  • History of inflammatory joint disease other than RA

Contact

Gail Lewis
University of South Florida - Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33612
Phone: 813-974-9509

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