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ORAL 1032

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oral 1032

 

Study of CP-690,550 Verus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

Purpose

This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

Condition

Intervention

Phase

Arthritis, Rheumatoid Drug: CP-690,550
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:Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

  • To compare the efficacy (ACR 20 response rates) of two doses of CP 690,550 versus placebo in rheumatoid arthritis subjects on background methotrexate who have had an inadequate response to a TNF inhibitor. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • To compare physical function status (HAQ DI response) of rheumatoid arthritis patients on background methotrexate who have had an inadequate response to a TNF inhibitor, after administration of two doses of CP 690,550 versus placebo. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • To compare the safety and tolerability of CP 690,550, in doses of 5 mg BID and 10 mg BID, versus placebo in patients with RA on background methotrexate who have had an inadequate response to a TNF inhibitor. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

 

Secondary Outcome Measures:

  • To compare the efficacy (ACR 20, 50, 70 and DAS28 response rates) of two doses of CP 690,550 versus placebo in rheumatoid arthritis subjects on background methotrexate who have had an inadequate response to a TNF inhibitor at visits other than Month 3. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To compare the durability of ACR20, ACR50, and ACR70 and DAS 28 response rates at each visit. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To compare the incidence of DAS 28 remission and low disease activity state at each visit. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To compare effects on all health outcomes measures in the study at each visit, as appropriate for the specific outcome, compared to baseline. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

 

Estimated Enrollment: 400
Study Start Date:
October 2009
Estimated Study Completion Date:
May 2011
Estimated Primary Completion Date:
May 2011 (Final data collection date for primary outcome measure)

 

Arms Assigned Interventions
Sequence 1: Experimental

Drug: CP 690,550

Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Sequence 2: Experimental

Drug: CP-690,550

Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.

Sequence 3:Placebo Comparator

Drug: Placebo

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.

Drug: CP-690,550

Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.

Sequence 4:Placebo Comparator

Biological: Biologic TNFi

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.

Drug: CP-690,550

Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.

 

Eligibility

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

 

Criteria

Inclusion Criteria:

  • Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

Exclusion Criteria:

  • Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

 

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