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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Pfizer
Study ID
NCT01164579
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tasocitinib plus Methotrexate — DRUG
    Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months
  • Tofacitinib plus placebo methotrexate — DRUG
    Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1.
  • Placebo tofacitinib plus Methotrexate — DRUG
    Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib

Study Details

Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.

Key Dates

Start date
Oct 31, 2010
Status verified
Apr 2015
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
109 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib (CP 690,550) 10 mg BID plus MTX
  • Experimental: Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX
  • Active Comparator: Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk

Primary Outcome Measure

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 ]

Locations (8)

FacilityCityStateZIPSite coordinators
ArthroCare, Arthritis Care & Research, PCGilbertArizona85234-
Talbert Medical GroupHuntington BeachCalifornia92646-
Inland Rheumatology Clinical Trials, Inc.UplandCalifornia91786-
Millennium ResearchOrmond BeachFlorida32174-
DMI Research, Inc.Pinellas ParkFlorida33782-
St. Petersburg Arthritis CenterSt. PetersburgFlorida33710-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104 5005-
Office of John P. Lavery, MD, PAAllenTexas75013-

Find similar trials in Gilbert, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
ArthroCare, Arthritis Care & Research, PC· Gilbert, AZTalbert Medical Group· Huntington Beach, CAInland Rheumatology Clinical Trials, Inc.· Upland, CAMillennium Research· Ormond Beach, FLDMI Research, Inc.· Pinellas Park, FLSt. Petersburg Arthritis Center· St. Petersburg, FL

Related Studies