Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01164579
• Date of registration: 15/07/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)
• Scientific title: An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis
• Date of first enrolment: October 2010
• Target sample size: 109
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01164579
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Argentina, Chile, Croatia, Czech Republic, Hungary, Mexico, Poland, Puerto Rico, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients with moderate to severe early rheumatoid arthritis (< 2 years) who are
methotrexate and biologic disease modifying antirheumatic drug naive.

Exclusion Criteria:

- Pregnant or lactating patients;

- Patients with renal or hepatic impairment or other severe or progressing disease;

- Patients with contraindication to magnetic resonance imaging with gadolinium contrast.



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo tofacitinib plus Methotrexate

Drug: Tasocitinib plus Methotrexate

Drug: Tofacitinib plus placebo methotrexate

Primary Outcome(s)

Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema [Time Frame: Month 6]

Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis [Time Frame: Month 3]

Secondary Outcome(s)

Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement) [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Change From Baseline in DAS28-4 (ESR) [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP]) [Time Frame: Baseline and Months 1, 2, 3, 6, 9, and 12]

Modified Total Sharp Score (mTSS) at Months 6 and 12 [Time Frame: Months 6 and 12]

Change From Baseline to Months 6 and 12 in JSN Scores [Time Frame: Months 6 and 12]

Joint Space Narrowing (JSN) Scores at Months 6 and 12 [Time Frame: Months 6 and 12]

Percentage of Participants With an ACR 70% Improvement (ACR70) Response [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Percentage of Participants With DAS28-4 (ESR) <2.6 [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement) [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions [Time Frame: Months 1, 3, 6, and 12]

Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis [Time Frame: Months 1, 6, and 12]

Percentage of Participants With DAS28-3 (CRP) Score <2.6 [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Percentage of Participants With DAS28-3 (CRP) Score ≤3.2 [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP [Time Frame: Months 1, 3, and 12]

Change From Baseline to Months 6 and 12 in Erosion Score [Time Frame: Months 6 and 12]

Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) [Time Frame: Baseline and Months 1, 2, 3, 6, 9, and 12]

Percentage of Participants With DAS28-4 (ESR) ≤3.2 [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Change From Baseline in DAS28-3 (CRP) [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Erosion Scores at Months 6 and 12 [Time Frame: Months 6 and 12]

Percentage of Participants With an ACR 50% Improvement (ACR50) Response [Time Frame: Months 1, 2, 3, 6, 9, and 12]

Change From Baseline to Months 6 and 12 in mTSS [Time Frame: Months 6 and 12]

Secondary ID(s)

2010-020890-18

A3921068

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/04/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01164579