Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00413699

Purpose

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after participating in another "qualifying" study of CP-690,550

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: CP-690,550	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Long-Term, Open-Label Follow-Up Study Of CP-690,550, A Moderately Selective Janus-Kinase-3 Inhibitor, For Treatment Of Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Primary endpoints will be standard laboratory safety data (chemistry, hematology, etc.) and adverse event (AE) reports [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: Yes ]
The long-term safety and tolerability of CP-690,550 5 mg BID and 10 mg BID for the treatment of rheumatoid arthritis [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent of patients with ACR 20, 50, and 70 responses [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
Area under ACR n curve [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
DAS 28 (CRP) and DAS 28 (ESR) [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
HAQ DI score [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
SF 36 score [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
Preservation of joint structure in patients who had baseline radiographs obtained in their qualifying index study [ Time Frame: Every 6 months until last observation. ] [ Designated as safety issue: No ]

Estimated Enrollment:	2500
Study Start Date:	February 2007
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open-Label Active Treatment Enrolled from Phase 2: Experimental Patients enrolling from Phase 2 studies	Drug: CP-690,550 5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
Open-Label Active Treatment Enrolled from Phase 3: Experimental Patients enrolling from Phase 3 studies	Drug: CP-690,550 10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

Exclusion Criteria:

Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413699

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 252 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 ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3921024
Study First Received:	December 18, 2006
Last Updated:	February 8, 2010
ClinicalTrials.gov Identifier:	NCT00413699 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

long-term open-label safety

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 08, 2010