A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2014-000352-29-CZ
• Date of registration: 05/08/2014
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc.
• Public title: A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).
• Scientific title: 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
• Date of first enrolment: 27/10/2014
• Target sample size: 560
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000352-29
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Estonia, France, Georgia, Germany, Hungary, Japan, Korea, Republic of, Lithuania, Mexico, New Zealand, Peru, Poland, Russian Federation, Serbia, South Africa, Spain, Taiwan, Ukraine, United Kingdom

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc.

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc.

Key inclusion & exclusion 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.
- 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

Health Condition(s) or Problem(s) studied

RHEUMATOID ARTHRITIS
MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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-

Primary Outcome(s)

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.

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.

Primary end point(s): Number of Participants With an American College of Rheumatology 20% (ACR20) Response

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: Visit 1-18

Secondary ID(s)

REFLECTIONS B538-02

B5381002

Source(s) of Monetary Support

Pfizer Inc.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 13/09/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000352-29/results