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

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ClinicalTrials.gov Identifier: NCT01393639
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: PF-04171327 Drug: prednisone Other: prednisone Other: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : September 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arms and Interventions
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Arm Intervention/treatment
Experimental: PF-04171327 1 mg QD Drug: PF-04171327
1 mg tablet once daily (QD) for 8 weeks
Experimental: PF-04171327 5 mg QD Drug: PF-04171327
5 mg tablet once daily (QD) for 8 weeks
Experimental: PF-04171327 10 mg QD Drug: PF-04171327
10 mg tablet once daily (QD) for 8 weeks
Experimental: PF-04171327 15 mg QD Drug: PF-04171327
15 mg tablet once daily (QD) for 8 weeks
Active Comparator: prednisone 5 mg QD Drug: prednisone
5 mg capsule once daily for 8 weeks
Active Comparator: prednisone 10 mg QD Other: prednisone
10 mg capsule once daily for 8 weeks
Placebo Comparator: placebo Other: placebo
placebo (tablet or capsule) once daily (QD) for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria [ Time Frame: baseline and week 8 ]
  2. Change in levels of dissociation biomarker P1NP measured in blood [ Time Frame: baseline and week 8 ]
  3. Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood [ Time Frame: baseline and week 8 ]

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

Eligibility Criteria
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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:

  • 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.
Contacts and Locations
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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): NCT01393639


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01393639    
Other Study ID Numbers: A9391010
2010-023782-22 ( EudraCT Number )
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Keywords provided by Pfizer:
treatment of rheumatoid arthritis
treatment of RA
patients on methotrexate for rheumatoid arthritis
prednisone for rheumatoid arthritis
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
 Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents