Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 December 2019 |
Main ID: |
EUCTR2014-000352-29-CZ |
Date of registration:
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05/08/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).
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Scientific title:
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A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY
TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN
INADEQUATE RESPONSE TO METHOTREXATE
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Date of first enrolment:
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27/10/2014 |
Target sample size:
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560 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000352-29 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Brazil
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Bulgaria
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Canada
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Colombia
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Croatia
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Czech Republic
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Estonia
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France
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Georgia
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Germany
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Hungary
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Japan
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Korea, Republic of
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Lithuania
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Mexico
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New Zealand
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Peru
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Poland
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Russian Federation
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Serbia
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South Africa
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Spain
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Taiwan
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Ukraine
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United Kingdom
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Contacts
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Name:
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Clinical Trials.gov Call Center
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Address:
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235 East 42nd Street
NY 10017
New York
United States |
Telephone:
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+18007181021 |
Email:
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ClinicalTrials.gov_Inquiries@pfizer.com |
Affiliation:
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Pfizer Inc. |
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Name:
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Clinical Trials.gov Call Center
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Address:
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235 East 42nd Street
NY 10017
New York
United States |
Telephone:
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+18007181021 |
Email:
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ClinicalTrials.gov_Inquiries@pfizer.com |
Affiliation:
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Pfizer Inc. |
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Key inclusion & exclusion criteria
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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.
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 420 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
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 (Disease modifying anti-rheumatic drug) must be washed out prior to the first study dose.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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RHEUMATOID ARTHRITIS
MedDRA version: 19.0
Level: PT
Classification code 10039073
Term: Rheumatoid arthritis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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Product Name: Adalimumab-Pfizer Product Code: PF-06410293 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Current Sponsor code: PF-06410293 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50-
Trade Name: HUMIRA Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB-EU CAS Number: 331731-18-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50-
Product Name: Adalimumab-Pfizer Product Code: PR-06410293 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: ADALIMUMAB Current Sponsor code: PF-06410293 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50-
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to compare the treatment efficacy between adalimumab-Pfizer and adalimumab-EU in subjects with moderately to severely active RA who are treated with adalimumab in combination with methotrexate.
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Secondary Objective: - To evaluate the overall safety and tolerability of adalimumab-Pfizer and adalimumab-EU. - To evaluate the immunogenicity of adalimumab-Pfizer and adalimumab-EU. - To evaluate multiple composite and individual parameters of clinical response to adalimumab-Pfizer and adalimumab-EU. - To evaluate the overall safety, tolerability and immunogenicity of adalimumab-Pfizer after treatment transition from adalimumab-EU to adalimumab-Pfizer. - To evaluate the population pharmacokinetics (PK) of adalimumab-Pfizer and adalimumab-EU. - To evaluate the pharmacodynamic (PD) response to adalimumab-Pfizer and adalimumab-EU.
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Timepoint(s) of evaluation of this end point: Week 12
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Primary end point(s): Number of Participants With an American College of Rheumatology 20% (ACR20) Response
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Secondary Outcome(s)
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Secondary end point(s): - Number of Participants With an American College of Rheumatology 20% (ACR20) Response
- Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
- Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
- Disease Activity Score Based on 28-joints Count (DAS28)-4(CRP)
- DAS Remission (=2.6)
- EULAR Response
- Change from baseline in individual components of ACR response
- Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (Nab)
- Serum drug concentration
- Type, incidence, severity, timing, seriousness and relatedness of events (AEs) and laboratory abnormalities.
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Timepoint(s) of evaluation of this end point: Visit 1-18
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Secondary ID(s)
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B5381002
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REFLECTIONS B538-02
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Source(s) of Monetary Support
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Pfizer Inc.
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Ethics review
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Status: Approved
Approval date:
Contact:
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