A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Pfizer
Study ID
NCT00550446
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — DRUG
    40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
  • CP-690-550 — DRUG
    15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
  • CP-690-550 — DRUG
    10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
  • CP-690-550 — DRUG
    5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
  • CP-690,550 — DRUG
    3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
  • CP-690,550 — DRUG
    1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
  • Placebo — DRUG
    Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)

Study Details

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

Key Dates

Start date
Sep 30, 2007
Status verified
Nov 2012
Primary completion
Jan 31, 2009
Completion
Jan 31, 2009

Study Design

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

Arms

  • Active Comparator: 1
  • Experimental: 2
  • Experimental: 3
  • Experimental: 4
  • Experimental: 5
  • Experimental: 6
  • Placebo Comparator: 7

Primary Outcome Measure

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

Locations (22)

FacilityCityStateZIPSite coordinators
Pfizer Investigational SiteMesaArizona85208-
Pfizer Investigational SiteLittle RockArkansas72205-
Pfizer Investigational SiteNorthridgeCalifornia91325-
Pfizer Investigational SitePalo AltoCalifornia94304-
Pfizer Investigational SiteStanfordCalifornia94305-
Pfizer Investigational SiteTarzanaCalifornia91356-
Pfizer Investigational SiteUplandCalifornia91786-
Pfizer Investigational SiteOrlandoFlorida32804-
Pfizer Investigational SiteTampaFlorida33614-
Pfizer Investigational SiteMorton GroveIllinois60053-
Pfizer Investigational SiteRockfordIllinois61107-
Pfizer Investigational SiteCedar RapidsIowa52401-2112-
Pfizer Investigational SiteWichitaKansas67203-
Pfizer Investigational SiteWichitaKansas67208-
Pfizer Investigational SiteNew OrleansLouisiana70115-
Pfizer Investigational SiteHickoryNorth Carolina28601-
Pfizer Investigational SiteHickoryNorth Carolina28602-
Pfizer Investigational SiteDaytonOhio45408-
Pfizer Investigational SiteDuncansvillePennsylvania16635-
Pfizer Investigational SiteKnoxvilleTennessee37909-1600-
Pfizer Investigational SiteDallasTexas75235-
Pfizer Investigational SiteMesquiteTexas75150-

Find similar trials in Mesa, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Pfizer Investigational Site· Mesa, AZPfizer Investigational Site· Little Rock, ARPfizer Investigational Site· Northridge, CAPfizer Investigational Site· Palo Alto, CAPfizer Investigational Site· Stanford, CAPfizer Investigational Site· Tarzana, CA

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