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

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:	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 Methotrexate sodium

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: 12 months ] [ Designated as safety issue: Yes ]
To compare the rate of achieving DAS28-4 (ESR) <2.6 after administration of CP‑690,550 in doses of 5 mg BID or 10 mg BID versus placebo at Month 6 in patients with active RA on a stable background of methotrexate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 <2.6 and DAS28 <or =3.2 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 metabolomic 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 ]
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: 12 & 24 months ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of 2 doses of CP-690,550 versus placebo. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment:	798
Study Start Date:	March 2009
Study Completion Date:	February 2012
Primary Completion Date:	April 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 (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period. Other Name: 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. Other Name: Double-blind, Active Extension Period
Experimental: Sequence 2	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. Other Name: 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. Other Name: Double-blind, Active Extension Period
Placebo Comparator: Sequence 3	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. Other Name: 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. Other Name: Double-blind, Active Extension Period
Placebo Comparator: Sequence 4	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. Other Name: Double-blind, Active Extension 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. Other Name: Double-blind, placebo-controlled 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 117 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
ClinicalTrials.gov Identifier:	NCT00847613 History of Changes
Other Study ID Numbers:	A3921044
Study First Received:	February 17, 2009
Last Updated:	February 28, 2012
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:

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 September 26, 2012