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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT00938587
Date of registration: 13/07/2009
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
Scientific title: A Phase 2a, Randomized, Double-Blind, Active And Placebo-Controlled Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
Date of first enrolment: October 2009
Target sample size: 86
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Czech Republic Czechia Hong Kong Hungary Korea, Republic of Russian Federation Serbia Singapore
Slovakia Spain Taiwan Turkey Ukraine United States
Name:     Pfizer Call Center
Affiliation:  Pfizer
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients = 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration
of 3 months

- On stable dose of methotrexate for at least 6 weeks prior to screening

- Patient must have minimum disease activity level of = 6 tender/painful joints, = 6
swollen joints and CRP = 0.7 mg/dL

- Not currently receiving steroid medication

Exclusion Criteria:

- Pregnant or nursing women

- Patients that have active infections, TB, HIV and/or Hepatitis B or C

- Patients that have a history of intolerance or significant adverse effects with the
use of glucocorticoids

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: PF-04171327 10 mg
Drug: PF-04171327 25 mg
Drug: Prednisone 5 mg
Other: Placebo
Other: Placebo for PF-04171327
Other: Prednisone Placebo
Primary Outcome(s)
DAS28-4 (CRP) [Time Frame: 14 days]
Secondary Outcome(s)
12-lead ECG [Time Frame: 14 days]
ACR 20/50/70 responder rate [Time Frame: 14 days]
Adverse events [Time Frame: 42 days]
Clinical laboratory abnormalities [Time Frame: 42 days]
CRP [Time Frame: 14 days]
DAS28-3 [Time Frame: 14 days]
Health Assessment Questionnaire-Disability Index [Time Frame: 14 days]
MTX clearance prior to dosing and in the presence of PF-00251802 [Time Frame: 14 days]
Patient Global Assessment of Arthritis and Arthritis Pain [Time Frame: 14 days]
Pharmacodynamic effects on biomarkers [Time Frame: 14 days]
Physician Global Assessment of Arthritis [Time Frame: 14 days]
SF-36 version 2 (acute) [Time Frame: 14 days]
Tender/painful and swollen joint count [Time Frame: 14 days]
Vital signs including weight [Time Frame: 42 days]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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