Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments pf-06438179, infliximab
Phase phase 3
Target TNF-alpha
Sponsor Pfizer
Start date August 2014
End date June 2016
Trial size 650 participants
Trial identifier NCT02222493, 2013-004148-49, B5371002, REFLECTIONS B537-02

Summary

The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
pf-06438179 Infliximab-Pfizer
PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
(Active Comparator)
infliximab Infliximab-EU, Remicade
Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Primary Outcomes

Measure
Number of Participants With an American College of Rheumatology 20% (ACR20) Response
time frame: 14 Weeks

Secondary Outcomes

Measure
Number of Participants With an American College of Rheumatology 20% (ACR20) Response
time frame: 30 Weeks
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
time frame: 30 Weeks
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
time frame: 30 Weeks
Disease Activity Score Based on 28-joints Count (DAS28)-CRP
time frame: 30 Weeks
DAS Remission
time frame: 30 Weeks
EULAR Response
time frame: 30 Weeks
Change from baseline in individual components of ACR response
time frame: 30 Weeks
Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (Nab) in response to infliximab-Pfizer and infliximab-EU
time frame: 30 Weeks
Serum drug concentration
time frame: 30 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 10 mg/L. Must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks. Exclusion Criteria: Evidence of untreated or inadequately treated latent or active TB. Evidence or history of moderate or severe heart failure (NYHA Class III/IV) Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.

Additional Information

Official title A Phase 3 Randomized, Double-Blind Study Assessing The Efficacy And Safety Of PF-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pfizer.