ORAL 1032

Study Of Tasocitinib (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 tasocitinib (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: Tasocitinib (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 Tasocitinib (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 tasocitinib (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 tasocitinib (CP-690,550) versus placebo. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
To compare the safety and tolerability of tasocitinib (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 tasocitinib (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: Tasocitinib (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: Tasocitinib (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: Tasocitinib (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: Tasocitinib (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 ClinicalTrials.gov.