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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00960440

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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: Cancer 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 rate of achieving DAS28 4(ESR) <2.6 in patients with active RA on background methotrexate who have had an inadequate response to a TNF inhibitor, after administration of CP 690,550, in doses of 5 mg BID and 10 mg BID, versus [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
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 incidence of DAS 28<2.6 and DAS28 <=3.2 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
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sequence 1	Drug: CP-690,550 Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
Experimental: Sequence 2	Drug: CP-690,550 Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.
Placebo Comparator: Sequence 3	Drug: Placebo Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period. Other Name: double-blind, placebo-controlled phase Drug: CP-690,550 Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period. Other Name: double-blind, extension phase
Placebo Comparator: Sequence 4	Drug: Placebo Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period. Other Name: double-blind, placebo-controlled phase Drug: CP-690,550 Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period. Other Name: double-blind, extension phase

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960440

Show 92 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00960440 History of Changes
Other Study ID Numbers:	A3921032
Study First Received:	August 14, 2009
Last Updated:	April 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

randomized double-blind placebo-controlled investigational drug oral therapy safety and efficacy

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012