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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00847613

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 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 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: Methotrexate

U.S. FDA Resources

Further study details as provided by Pfizer:

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. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
To compare evidence of preservation of joint structure following administration of 2 doses CP-690,550 versus placebo as measured by changes from baseline. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To compare physical function status of patients after administration of 2 doses of CP-690,550 versus placebo using the HAQ-DI. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of 2 doses of CP-690,550 versus placebo. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To compare the durability of ACR20, ACR50, and ACR70 and DAS 28 response rates. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To compare the incidence of DAS 28 remission and low disease activity state at each visit. [ Time Frame: 2 years ] [ 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: 2 years ] [ Designated as safety issue: No ]
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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847613

Show 118 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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3921044
Study First Received:	February 17, 2009
Last Updated:	March 16, 2010
ClinicalTrials.gov Identifier:	NCT00847613 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

double-blind placebo-controlled investigational drug oral therapy safety and efficacy hand and feet x-rays

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases

Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on March 18, 2010