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An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

NCT00383188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2021-08-20

Study results available
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Summary

Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.

Conditions

  • Arthritis, Rheumatoid

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-15
Primary Completion
2008-07-01
Completion
2008-07-16

Countries

  • Australia
  • Brazil
  • Chile
  • Czechia
  • Estonia
  • India
  • Peru
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT00383188 on ClinicalTrials.gov