A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Pfizer

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: PF-06410293

Biological: Adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02480153

B5381002, REFLECTIONS B538-02

B5381002

ADALIMUMAB (Other Identifier)

2014-000352-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

597 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.

Exclusion criteria

Evidence of untreated or inadequately treated latent or active TB.
Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
Any second DMARD must be washed out prior to the first study dose.