| An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
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| 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
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| Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
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| Not Provided
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| Interventional
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| Phase 2
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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| Arthritis, Rheumatoid
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- Drug: placebo
Capsule, once daily (QD) for 12 weeks
- Drug: PH-797804
Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks
- Drug: PH-797804
Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks
- Drug: PH-797804
Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks
- Drug: PH-797804
Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks
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- Placebo Comparator: 1
Intervention: Drug: placebo
- Experimental: 2
Intervention: Drug: PH-797804
- Experimental: 3
Intervention: Drug: PH-797804
- Experimental: 4
Intervention: Drug: PH-797804
- Experimental: 5
Intervention: Drug: PH-797804
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| Not Provided
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| |
| Completed
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| 305
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| 290
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| July 2008
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| Not Provided
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|
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
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| Sexes Eligible for Study: |
All |
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| 18 Years and older (Adult, Older Adult)
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| No
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|
Contact information is only displayed when the study is recruiting subjects
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| Australia, Brazil, Chile, Czech Republic, Estonia, India, Korea, Republic of, Peru, Poland, Russian Federation, South Africa, Spain
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|
|
| |
| NCT00383188
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| A6631007
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| No
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| Not Provided
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| Not Provided
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| Director, Clinical Trial Disclosure Group, Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| October 2009
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