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A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02222493
Recruitment Status : Completed
First Posted : August 21, 2014
Results First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: PF-06438179 Biological: Infliximab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 26, 2014
Actual Primary Completion Date : June 29, 2016
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PF-06438179 Biological: PF-06438179
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.
Other Name: Infliximab-Pfizer
Active Comparator: Infliximab Biological: Infliximab
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.
Other Name: Infliximab-EU, Remicade

Primary Outcome Measures :
  1. Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14 in the Intent-to-Treat (ITT) Population [ Time Frame: Week 0, Week 2, Week 4, Week 6, Week 12, and Week 14 ]
    ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02222493

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT02222493     History of Changes
Other Study ID Numbers: B5371002
REFLECTIONS B537-02 ( Other Identifier: Alias ID )
2013-004148-49 ( EudraCT Number )
First Posted: August 21, 2014    Key Record Dates
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017
Last Verified: August 2017

Keywords provided by Pfizer:
Phase 3
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents