A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
Recruiting in Palo Alto (17 mi)
+182 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pfizer
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.
Research Team
PC
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
Inclusion Criteria
Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
Hs-CRP equal or greater than 8 mg/L.
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Treatment Details
Interventions
- Adalimumab (TNF-alpha inhibitor)
- PF-06410293 (TNF-alpha inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: PF-06410293Experimental Treatment1 Intervention
Group II: AdalimumabActive Control1 Intervention
Adalimumab is already approved in Canada, Japan for the following indications:
Approved in Canada as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
Approved in Japan as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Altoona Center for Clinical ResearchDuncansville, PA
Clinical Research of Reading, LLCWyomissing, PA
Low Country Rheumatology, PACharleston, SC
Regional Health Clinical ResearchRapid City, SD
More Trial Locations
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Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4712
Patients Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
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