A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 25, 2007

Last Updated Date

March 5, 2009

Start Date ^†

September 2007

Current Primary Outcome Measures ^†

American College of Rheumatology 20 (ACR 20) responder rate at the Week 12 visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00550446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Incidence and severity of adverse events after switch from adalimumab to CP- 690,550 compared to CP-690,550 alone [ Time Frame: All timepoints during study ] [ Designated as safety issue: Yes ]
Categorical summary of absolute vital signs and vital signs changes compared to baseline by subject [ Time Frame: All timepoints during study ] [ Designated as safety issue: Yes ]
The ACR 20 Responder rate (in addition to week 12) [ Time Frame: All timepoints during study other than week 12 ] [ Designated as safety issue: No ]
ACR 50 Responder rate [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
ACR 90 Responder rate [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Area under the ACR n curve [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Actual and change from baseline in FACS lymphocyte biomarkers. [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Mean change from baseline in vital signs (blood pressure, heart rate, and oral or tympanic temperature) measurements [ Time Frame: All timepoints during study ] [ Designated as safety issue: Yes ]
Actual and change from baseline in the FACIT Fatigue Scale [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Actual and change from baseline in the Medical Outcomes Study (MOS) Sleep Scale [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Actual and change from baseline in serum IgG, IgM and IgA levels [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Actual and change from baseline in disease activity, assessed as the [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
ACR 70 Responder rate [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Actual and change from baseline in the SF 36 Health Questionnaire [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Actual and change from baseline in the EuroQol EQ 5D [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Actual and change from baseline of the 7 individual components of the ACR 20, 50, 70, and 90 response criteria [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Actual and change from baseline in the Health Assessment Questionnaire (HAQ DI) [ Time Frame: All timepoints during study ] [ Designated as safety issue: No ]
Incidence and severity of adverse events [ Time Frame: All timepoints during study ] [ Designated as safety issue: Yes ]
Incidence and severity of clinical laboratory abnormalities [ Time Frame: All timepoints during study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

Official Title ^†

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

Brief Summary

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Arthritis, Rheumatoid

Intervention ^†

Drug: Adalimumab
Drug: CP-690-550
Drug: CP-690,550
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

350

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Subjects must have active rheumatoid arthritis
Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion Criteria:

Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
Subjects who previously received adalimumab (Humira®) therapy for any reason.
Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Germany, Greece, Hungary, Italy, Korea, Republic of, Mexico, Romania, Slovakia, Ukraine

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00550446

Responsible Party

Director, Clinical Trial Disclosure, Pfizer Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.