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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02480153
• Date of registration: 19/06/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• 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: June 25, 2015
• Target sample size: 597
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02480153
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

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.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Adalimumab

Biological: PF-06410293

Primary Outcome(s)

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1 [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3 [Time Frame: Baseline, Weeks 52, 56, 66, 76 and 78]

Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response:Period 1 [Time Frame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2 [Time Frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2 [Time Frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1 [Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Change From Baseline in Swollen Joint Count: Period 1 [Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Change From Baseline in Swollen Joint Count: Period 3 [Time Frame: Baseline, Weeks 52, 56, 66, 76 and 78]

Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2 [Time Frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1 [Time Frame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Number of Participants With Laboratory Abnormalities: Period 2 [Time Frame: Week 26 dosing up to Week 52 (pre-dose)]

Serum Concentration Versus Time Summary: Period 3 [Time Frame: Pre-dose on Days 365, 393, 463, 547 and 575]

Change From Baseline in Swollen Joint Count: Period 2 [Time Frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1 [Time Frame: Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)]

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3 [Time Frame: Week 52 dosing up to follow-up visit (Week 92)]

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 [Time Frame: Baseline (Day 1) up to Week 26 (pre-dose)]

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1 [Time Frame: Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3 [Time Frame: Baseline, Weeks 52, 56, 66, 76 and 78]

Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1 [Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1 [Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2 [Time Frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Change From Baseline in Tender Joint Count: Period 2 [Time Frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Change From Baseline in Tender Joint Count: Period 3 [Time Frame: Baseline, Weeks 52, 56, 66, 76 and 78]

Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3 [Time Frame: Weeks 52, 56, 66, 76 and 78]

Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1 [Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3 [Time Frame: Weeks 52, 56, 66, 76 and 78]

Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3 [Time Frame: Weeks 52, 56, 66, 76 and 78]

Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1 [Time Frame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Number of Participants With Laboratory Abnormalities: Period 3 [Time Frame: Week 52 dosing up to follow-up visit (Week 92)]

Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2 [Time Frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2 [Time Frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3 [Time Frame: Baseline, Weeks 52, 56, 66, 76 and 78]

Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3 [Time Frame: Baseline, Weeks 52, 56, 66, 76 and 78]

Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2 [Time Frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2 [Time Frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2 [Time Frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3 [Time Frame: Baseline, Weeks 52, 56, 66, 76 and 78]

Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2 [Time Frame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Change From Baseline in Tender Joint Count: Period 1 [Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2 [Time Frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3 [Time Frame: Weeks 52, 56, 66, 76 and 78]

Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3 [Time Frame: Weeks 52, 56, 66, 76 and 78]

Serum Concentration Versus Time Summary: Period 1 [Time Frame: Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit]

Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3 [Time Frame: Baseline, Weeks 52, 56, 66, 76 and 78]

Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1 [Time Frame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2 [Time Frame: Weeks 26, 30, 36, 44 and 52 (pre-dose)]

Number of Participants With Laboratory Abnormalities: Period 1 [Time Frame: Baseline (Day 1) up to Week 26 (pre-dose)]

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1 [Time Frame: Baseline up to Week 26 (pre-dose)]

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 [Time Frame: Week 26 dosing up to Week 52 (pre-dose)]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1 [Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1 [Time Frame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)]

Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3 [Time Frame: Weeks 52, 56, 66, 76 and 78]

Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2 [Time Frame: Week 26 dosing up to Week 52 (pre-dose)]

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 [Time Frame: Week 52 dosing up to follow-up visit (Week 92)]

Serum Concentration Versus Time Summary: Period 2 [Time Frame: Pre-dose on Days 183, 211, 253 and 365]

Secondary ID(s)

B5381002

ADALIMUMAB

B5381002, REFLECTIONS B538-02

2014-000352-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/09/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02480153