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

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Locations

United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States, 85208
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Palo Alto, California, United States, 94304
Pfizer Investigational Site
Tarzana, California, United States, 91356
Pfizer Investigational Site
Upland, California, United States, 91786
Pfizer Investigational Site
Northridge, California, United States, 91325
Pfizer Investigational Site
Stanford, California, United States, 94305
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33614
Pfizer Investigational Site
Orlando, Florida, United States, 32804
United States, Illinois
Pfizer Investigational Site
Rockford, Illinois, United States, 61107
Pfizer Investigational Site
Morton Grove, Illinois, United States, 60053
United States, Iowa
Pfizer Investigational Site
Cedar Rapids, Iowa, United States, 52401-2112
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67208
Pfizer Investigational Site
Wichita, Kansas, United States, 67203
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70115
United States, North Carolina
Pfizer Investigational Site
Hickory, North Carolina, United States, 28601
Pfizer Investigational Site
Hickory, North Carolina, United States, 28602
United States, Ohio
Pfizer Investigational Site
Dayton, Ohio, United States, 45408
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37909-1600
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75235
Pfizer Investigational Site
Mesquite, Texas, United States, 75150
Brazil, RS
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90035-903
Brazil, SP
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01323-903
Bulgaria
Pfizer Investigational Site
Sofia, Bulgaria, 1612
Pfizer Investigational Site
Sofia, Bulgaria, 1709
Pfizer Investigational Site
Sofia 1606, Bulgaria
Pfizer Investigational Site
Pleven, Bulgaria, 5800
Chile, RM
Pfizer Investigational Site
Santiago, RM, Chile, 8331030
Pfizer Investigational Site
Santiago, RM, Chile, 8360156
Chile, Santiago, RM
Pfizer Investigational Site
Providencia, Santiago, RM, Chile, 7530206
Croatia
Pfizer Investigational Site
Zagreb, Croatia, 10000
Pfizer Investigational Site
Split, Croatia, 21000
Czech Republic
Pfizer Investigational Site
Praha 11 - Chodov, Czech Republic, 148 00
Pfizer Investigational Site
Zlin, Czech Republic, 760 01
Pfizer Investigational Site
Brno, Czech Republic, 656 91
Pfizer Investigational Site
Praha 4, Czech Republic, 140 59
Pfizer Investigational Site
Praha 2, Czech Republic, 128 50
Germany
Pfizer Investigational Site
Leipzig, Germany, 04103
Pfizer Investigational Site
Hildesheim, Germany, 31134
Pfizer Investigational Site
Dresden, Germany, 01067
Pfizer Investigational Site
Hamburg, Germany, 22081
Greece
Pfizer Investigational Site
Thessaloniki, Greece, 54 636
Greece, Athens
Pfizer Investigational Site
Goudi, Athens, Greece, 11527
Hungary
Pfizer Investigational Site
Szolnok, Hungary, H-5000
Italy
Pfizer Investigational Site
Firenze, Italy, 50139
Pfizer Investigational Site
Genova, Italy, 16132
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 133-792
Mexico, D.F.
Pfizer Investigational Site
Mexico, D.F., Mexico, 06100
Mexico, Estado de Mexico
Pfizer Investigational Site
Metepec, Estado de Mexico, Mexico, 52140
Mexico, Jalisco
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44650
Mexico, Morelos
Pfizer Investigational Site
Cuernavaca, Morelos, Mexico, 62270
Romania
Pfizer Investigational Site
Bucuresti, Romania, 011172
Pfizer Investigational Site
Constanta, Romania, 900591
Pfizer Investigational Site
Iasi, Romania, 700661
Slovakia
Pfizer Investigational Site
Zilina, Slovakia, 012 07
Pfizer Investigational Site
Piestany, Slovakia, 921 12
Ukraine
Pfizer Investigational Site
Kharkiv, Ukraine, 61000
Pfizer Investigational Site
Kyiv, Ukraine, 04114
Pfizer Investigational Site
Zaporizhzhia, Ukraine, 69118
Pfizer Investigational Site
Lviv, Ukraine, 79011
Pfizer Investigational Site
Vinnitsa, Ukraine, 21018

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 11, 2009