Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.

Official Title
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A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: PF-04171327
* Drug: PF-04171327
* Drug: PF-04171327
* Drug: PF-04171327
* Drug: prednisone
* Other: prednisone
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, must have been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis, and must be free of any signs or symptoms of infection. Exclusion Criteria: Subjects cannot enter the study if they have recently received treatment with certain medications which might interfere with study medications; subjects cannot enter if they have abnormalities in certain blood tests, history of cancer, recent bone fracture or other significant conditions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04171327 1 mg QD<br> | Drug: PF-04171327<br>* 1 mg tablet once daily (QD) for 8 weeks<br>|
| Experimental: PF-04171327 5 mg QD<br> | Drug: PF-04171327<br>* 5 mg tablet once daily (QD) for 8 weeks<br>|
| Experimental: PF-04171327 10 mg QD<br> | Drug: PF-04171327<br>* 10 mg tablet once daily (QD) for 8 weeks<br>|
| Experimental: PF-04171327 15 mg QD<br> | Drug: PF-04171327<br>* 15 mg tablet once daily (QD) for 8 weeks<br>|
| Active Comparator: prednisone 5 mg QD<br> | Drug: prednisone<br>* 5 mg capsule once daily for 8 weeks<br>|
| Active Comparator: prednisone 10 mg QD<br> | Other: prednisone<br>* 10 mg capsule once daily for 8 weeks<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* placebo (tablet or capsule) once daily (QD) for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria |  | baseline and week 8 | 
| Change in levels of dissociation biomarker P1NP measured in blood |  | baseline and week 8 | 
| Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood |  | baseline and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants achieving a 20% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe |  | baseline and Week 2, 4, 12 | 
| Number of participants achieving a 50% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe |  | baseline and Week 2,4,6,8,12 | 
| Change in Disease Activity Score (DAS) 28-3 using C-reactive protein (CRP) from baseline to multiple timepoints listed in timeframe |  | baseline and Week 2,4,6,8,12 | 
| Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe |  | baseline and Week 4,8,12 | 
| Number of participants achieving a 70% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe |  | baseline and Week 2,4,6,8,12 | 
| Change in Disease Activity Score (DAS)-4 using C-reactive protein(CRP) from baseline to multiple timepoints listed in timeframe |  | baseline and Week 2,4,6,8,12 | 
| Number of participants achieving improvement according to ACR hybrid criteria from baseline to multiple timepoints listed in timeframe |  | baseline and Week 2,4,6,8,12 | 
| Number of participants achieving improvement in individual components of the ACR criteria from baseline to multiple timepoints listed in timeframe |  | baseline and Week 2,4,6,8,12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment of rheumatoid arthritis, treatment of RA, patients on methotrexate for rheumatoid arthritis, prednisone for rheumatoid arthritis