Find out if you qualify for one of the ORAL trials. Apply online or call 866-439-6626.

Know someone with RA? Send a link to tell them about the ORAL trials. Email a friend.

ORAL 1044

Bookmark and Share
oral 1044

 

2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Purpose

This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

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 Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Primary Outcome Measures:

  • To compare the efficacy of 2 doses of CP-690,550 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis as measured by ACR 20 response rates.
  • To compare evidence of preservation of joint structure following administration of 2 doses CP-690,550 versus placebo as measured by changes from baseline.
  • To compare physical function status of patients after administration of 2 doses of CP-690,550 versus placebo using the HAQ-DI.
  • To evaluate the safety and tolerability of 2 doses of CP-690,550 versus placebo.

 

Secondary Outcome Measures:

  • To compare the efficacy of 2 doses of CP-690,550 versus placebo measured by ACR20, ACR 50, ACR70 and DAS 28 response rates.
  • To compare the durability of ACR20, ACR50, and ACR70 and DAS 28 response rates.
  • To compare the incidence of DAS 28 remission and low disease activity state at each visit.
  • To compare effects on all health outcomes measures in the study at each visit, as appropriate for the specific outcome, compared to baseline.
  • To investigate possible associations between genomic and metabonomic variation in relation to interventions in an optional supplement requiring separate consent not required for participation in primary study.

 

Estimated Enrollment: 750
Study Start Date:
April 2009
Estimated Study Completion Date:
February 2012
Estimated Primary Completion Date:
February 2012 (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 (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Drug: CP-690,550

Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

Sequence 2: Experimental

Drug: CP-690,550

Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Drug: CP-690,550

Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

Sequence 3: Placebo Comparator

Drug: Placebo

Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Drug: CP-690,550

Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

Sequence 4: Placebo Comparator

Drug: Placebo

Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Drug: CP-690,550

Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension 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

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.