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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00550446

Purpose

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.)

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

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

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

Further study details as provided by Pfizer:

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 ]

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 ]

Estimated Enrollment:	350
Study Start Date:	September 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Adalimumab 40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
2: Experimental	Drug: CP-690-550 15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
3: Experimental	Drug: CP-690-550 10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
4: Experimental	Drug: CP-690-550 5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
5: Experimental	Drug: CP-690,550 3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
6: Experimental	Drug: CP-690,550 1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
7: Placebo Comparator	Drug: Placebo Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550446

Show 63 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 )
Study ID Numbers:	A3921035
Study First Received:	October 25, 2007
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00550446 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Janus Kinase 3 Clinical Trial

Study placed in the following topic categories:

Anti-Inflammatory Agents
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antirheumatic Agents
Adalimumab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Pharmacologic Actions
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 06, 2009