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ORAL 1064

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oral 1064

 

Phase 3 Study Comparing 2 Doses of CP-690,550 and the Active Comparator, Humira (Adalimumab) vs. Placebo for Treatment of Rheumatoid Arthritis

Purpose

This is a comparative Phase 3 study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies. An active comparator, adalimumab, is also included.

Condition

Intervention

Phase

Arthritis, Rheumatoid Drug: CP-690,550
Other: Placebo
Biological: Biologic TNFi
Drug: Placebo
Phase 3

 

Study Type: Interventional

Study Design:Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Official Title:PPhase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of CP 690,550 in Patients With Active Rheumatoid Arthritis on Background Methotrexate

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

  • American College of Rheumatology 20 (ACR20) responder rate versus placebo [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in the Health Assessment Questionnaire (HAQ DI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events and clinical laboratory abnormalities [ Time Frame: all time points ] [ Designated as safety issue: Yes ]

 

Secondary Outcome Measures:

  • ACR20 responder rates [ Time Frame: all time points ] [ Designated as safety issue: No ]
  • ACR50 responder rates [ Time Frame: all time points ] [ Designated as safety issue: No ]
  • ACR70 responder rates [ Time Frame: all time point ] [ Designated as safety issue: No ]
  • DAS 28 and HAQ DI [ Time Frame: all time points ] [ Designated as safety issue: No ]
  • DAS 28 remission and low disease activity [ Time Frame: all time points ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: all time points ] [ Designated as safety issue: No ]
  • MOS Sleep Scale, FACIT Fatigue Scale, Eur QoL EQ5D, RA Healthcare Resource Utilization Questionnaire, and Work Limitations Questionnaire [ Time Frame: Month 1, 3, 6 and 12 ] [ Designated as safety issue: No ]

 

Estimated Enrollment: 700
Study Start Date:
May 2009
Estimated Study Completion Date:
March 2011
Estimated Primary Completion Date:
March 2011 (Final data collection date for primary outcome measure)

 

Arms Assigned Interventions
Active 5mg: Experimental

Drug: CP 690,550

tablets 5 mg BID PO and q2 week placebo SC injections for 12 months

Active 10 mg: Experimental

Other: CP-690,550

tablets placebo BID PO advance tablets to 5mg CP 690,550 BID at Month 3 or 6 visit and q2 week placebo SC injections for 12 months

Placebo Sequence 1:Placebo Comparator

Other: Placebo

tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit and q2 week placebo SC injections for 12 months

Placebo Sequence 2:Placebo Comparator

Biological: Biologic TNFi

40 mg q2 week SC injections for 12 months and placebo tablets BID PO

Adalimumab:Active Comparator

Biological: Biologic TNFi

Biological: Biologic TNFi 40 mg q2 week SC injections for 12 months and placebo tablets BID PO

 

Eligibility

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

 

Criteria

Inclusion Criteria:

  • The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
  • The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
  • The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria:

  • Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L
  • History of any other autoimmune rheumatic disease other than Sjogren's syndrome
  • No malignancy or history of malignancy.
  • History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
  • Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
  • Patients who have previously received adalimumab therapy for any reason.
  • Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
  • Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure

 

This information is also available at www.clinicaltrials.gov Last updated September 29, 2009.