NCT03682705

A Study to Investigate the Safety and Efficacy of an Active Drug Alone or in Combination With an Active Drug (Active Drug Combination) in Participants With Active Rheumatoid Arthritis.

Brief summary

This is a phase 2 study to evaluate safety and efficacy of a combination of active drugs vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDS) for the treatment of signs and symptoms of Rheumatoid Arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs(bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.

Interventional study

Status:
Completed
Conditions:
Rheumatoid Arthritis (RA)
Enrollment:
242 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-063
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months based on the 2010 American
College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification
criteria for RA

- Participant meets the following minimum disease activity criteria:

- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68
joint counts) at Screening and Baseline Visits

- High-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L (central lab) at Screening
Visit

- Participants must have been treated for ≥ 3 months with ≥ 1 biologic disease-modifying
anti-rheumatic drug (bDMARD) therapy but continue to exhibit active RA or had to
discontinue due to intolerability or toxicity, irrespective of treatment duration

- Participants must have been receiving conventional synthetic disease-modifying
anti-rheumatic drug (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks
prior to the first dose of study drug

- Participants must have discontinued all bDMARDs prior to the first dose of study drug

Exclusion Criteria:

- Participant has prior exposure to any Janus Kinase (JAK) inhibitor for greater than 2
weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and
filgotinib). A washout period of ≥ 30 days is required for any JAK inhibitor prior to the
first dose of study drug.

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