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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01393639
Date of registration: 13/06/2011
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
Scientific 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.
Date of first enrolment: September 2011
Target sample size: 323
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01393639
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
Bulgaria Canada Colombia Czech Republic Czechia Germany Hungary India
Korea, Republic of Malaysia Mexico Poland Romania Russian Federation Serbia Slovakia
South Africa Spain Ukraine United States
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: PF-04171327
Drug: prednisone
Other: placebo
Other: prednisone
Primary Outcome(s)
Change in levels of dissociation biomarker P1NP measured in blood [Time Frame: baseline and week 8]
Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood [Time Frame: baseline and week 8]
Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria [Time Frame: baseline and week 8]
Secondary Outcome(s)
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]
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]
Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe [Time Frame: baseline and Week 4,8,12]
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]
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]
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]
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]
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]
Secondary ID(s)
2010-023782-22
A9391010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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