Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02969044
• Date of registration: 17/11/2016
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
• Scientific title: A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate
• Date of first enrolment: December 20, 2016
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02969044
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Czechia, Georgia, Germany, Hungary, Poland, Serbia, Slovakia, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria

- Subjects between the ages of 18 and 75 years, inclusive

- Must have moderate-to-severe, active Rheumatoid Arthritis

- Must have had an inadequate response to Methotrexate

- Subjects may have received one approved TNF inhibiting biologic agent that was
inadequately effective and/or not tolerated

Exclusion Criteria

- Subjects with any acute or chronic infections or infection history

- Have acute or active chronic dermatological disorders prior to study start

- Any major illness/condition(s) or evidence of an unstable clinical condition that in
the judgment of the investigator would make the subject inappropriate for entry into
this study

- Known immunodeficiency disorder or a first degree relative with hereditary
immunodeficiency

- Any live (attenuated) vaccines or current routine household contact with anyone who
has received live (attenuated) vaccine



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo

Drug: PF-06651600

Primary Outcome(s)

Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 [Time Frame: Baseline, Week 8]

Secondary Outcome(s)

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8 [Time Frame: Baseline, Week 1, 2, 4, 6 and 8]

Number of Participants With Laboratory Abnormalities [Time Frame: Baseline up to Week 12]

Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) [Time Frame: Week 4, 6 and 8]

Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8 [Time Frame: Baseline, Week 1, 2, 4, 6 and 8]

Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8 [Time Frame: Baseline, Week 1, 2, 4, 6 and 8]

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8 [Time Frame: Baseline, Week 1, 2, 4, 6 and 8]

Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 [Time Frame: Baseline, Week 1, 2, 4, 6 and 8]

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Week 12]

Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) [Time Frame: Week 4, 6 and 8]

Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8 [Time Frame: Baseline, Week 1, 2, 4, 6 and 8]

Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 [Time Frame: Baseline, Week 1, 2, 4 and 6]

Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 [Time Frame: Baseline, Week 1, 2, 4, 6 and 8]

Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) [Time Frame: Week 4, 6 and 8]

Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) [Time Frame: Week 4, 6 and 8]

Remission Rate Based on Simple Disease Activity Index Score [Time Frame: Week 4, 6 and 8]

Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 [Time Frame: Baseline, Week 1, 2, 4, 6 and 8]

Number of Participants With Vital Signs Abnormalities [Time Frame: Baseline up to Week 12]

Secondary ID(s)

2016-002862-30

B7981006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02969044