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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01393639
First received: June 13, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: PF-04171327
Drug: prednisone
Other: prednisone
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
  • Change in levels of dissociation biomarker P1NP measured in blood [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]
  • Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 4,8,12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 323
Study Start Date: September 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393639

  Show 90 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01393639     History of Changes
Other Study ID Numbers: A9391010
Study First Received: June 13, 2011
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

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:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2014