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An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00383188
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : October 12, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: placebo Drug: PH-797804 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week, Phase 2A, Randomized, Double-Blind, Placebo-Controlled Study To Investigate The Safety, Pharmacokinetics, And Efficacy Of PH-797804, Administered Orally Once Daily In Subjects With Active Rheumatoid Arthritis
Study Start Date : December 2006
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 1 Drug: placebo
Capsule, once daily (QD) for 12 weeks

Experimental: 2 Drug: PH-797804
Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks

Experimental: 3 Drug: PH-797804
Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks

Experimental: 4 Drug: PH-797804
Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks

Experimental: 5 Drug: PH-797804
Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks




Primary Outcome Measures :
  1. Is PH-797804, a p38 inhibitor, safe and tolerated as a monotherapy agent for 12 weeks in subjects with RA and who have failed at least 1 DMARD [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Is PH-797804, a p38 inhibitor, efficacious in the selected dose range with additional characterization by PK in a 12-week treatment period in subjects with RA and who have failed at least 1 DMARD [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with RA and has failed at least 1 DMARD therapy

Exclusion Criteria:

  • Any other inflammatory arthritis and any significant history of acute or chronic infection with immunomodulatory etiology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383188


Locations
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Australia, Victoria
Pfizer Investigational Site
Malvern East, Victoria, Australia, 3145
Brazil
Pfizer Investigational Site
Curitiba, Paraná, Brazil, 80060-240
Pfizer Investigational Site
Curitiba, PR, Brazil, 80060-900
Pfizer Investigational Site
São Paulo, SP, Brazil, 04026-000
Pfizer Investigational Site
São Paulo, SP, Brazil, 04230-000
Chile
Pfizer Investigational Site
Santiago, RM, Chile, 7500922
Pfizer Investigational Site
Santiago, RM, Chile, 8331030
Pfizer Investigational Site
Santiago, RM, Chile, 8360156
Pfizer Investigational Site
Viña Del Mar, V Region, Chile, 2570017
Pfizer Investigational Site
Rancagua, VI Región, Chile
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 656 91
Pfizer Investigational Site
Olomouc, Czech Republic, 775 20
Pfizer Investigational Site
Ostrava - Trebovice, Czech Republic, 722 00
Pfizer Investigational Site
Praha 2, Czech Republic, 128 50
Pfizer Investigational Site
Praha 4, Czech Republic, 140 59
Pfizer Investigational Site
Zlin, Czech Republic, 760 01
Estonia
Pfizer Investigational Site
Tallinn, Estonia, 11312
Pfizer Investigational Site
Tallinn, Estonia, 13419
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 034
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 082
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 034
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 008
Pfizer Investigational Site
Ludhiana, Punjab, India, 141001
Pfizer Investigational Site
Coimbatore, Tamil Nadu, India, 641 014
Korea, Republic of
Pfizer Investigational Site
Anyang, Korea, Republic of, 431-070
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 133-792
Pfizer Investigational Site
Seoul, Korea, Republic of
Peru
Pfizer Investigational Site
Lima, Peru, L-27
Pfizer Investigational Site
Lima, Peru, L27
Pfizer Investigational Site
Lima, Peru, L33
Poland
Pfizer Investigational Site
Bialystok, Poland, 15-950
Pfizer Investigational Site
Bialystok, Poland, 16-461
Pfizer Investigational Site
Poznan, Poland, 60-773
Pfizer Investigational Site
Warszawa, Poland, 02-256
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 115093
Pfizer Investigational Site
Moscow, Russian Federation, 115446
Pfizer Investigational Site
Smolensk, Russian Federation, 214019
Pfizer Investigational Site
St. Petersburg, Russian Federation, 190000
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194291
South Africa
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa, 1619
Pfizer Investigational Site
Parktown, Johannesburg, South Africa, 2193
Pfizer Investigational Site
Bloemfontein, South Africa, 9317
Pfizer Investigational Site
Durban, South Africa, 4001
Pfizer Investigational Site
Kempton Park, South Africa
Pfizer Investigational Site
Pretoria, South Africa, 0081
Spain
Pfizer Investigational Site
Barakaldo, Vizcaya, Spain, 48903
Pfizer Investigational Site
Sevilla, Spain, 41014
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00383188    
Other Study ID Numbers: A6631007
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: October 12, 2009
Last Verified: October 2009
Keywords provided by Pfizer:
Arthritis, Rheumatoid
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases