TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Sponsor
Pfizer
Study ID
NCT04413617
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • PF-06650833 — DRUG
    400 mg
  • PF-06651600 — DRUG
    100 mg
  • Tofacitinib — DRUG
    11 mg

Study Details

Dual objectives of increased efficacy compared to currently available SoC RA drugs and maintaining a favourable benefit - risk relationship.

Key Dates

Start date
Jul 29, 2020
Status verified
Mar 2023
Primary completion
Feb 7, 2022
Completion
Feb 7, 2022

Study Design

Enrollment
460 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PF-06650833 + tofacitinib
  • Experimental: PF-06650833 + PF-06651600
  • Experimental: PF-06650833
  • Experimental: PF-06651600
  • Experimental: Tofacitinib

Primary Outcome Measure

Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 [ Time Frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12 ]

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