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

NCT01393639 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2024-09-04

Study results available
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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.

Conditions

Interventions

DRUG

PF-04171327

1 mg tablet once daily (QD) for 8 weeks

DRUG

PF-04171327

5 mg tablet once daily (QD) for 8 weeks

DRUG

PF-04171327

10 mg tablet once daily (QD) for 8 weeks

DRUG

PF-04171327

15 mg tablet once daily (QD) for 8 weeks

DRUG

prednisone

5 mg capsule once daily for 8 weeks

OTHER

prednisone

10 mg capsule once daily for 8 weeks

OTHER

placebo

placebo (tablet or capsule) once daily (QD) for 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-27
Primary Completion
2014-06-03
Completion
2014-06-09

Countries

  • United States
  • Bulgaria
  • Colombia
  • Czechia
  • Germany
  • Hungary
  • India
  • Malaysia
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01393639 on ClinicalTrials.gov