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

• 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
• 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)

Other: prednisone

Drug: prednisone

Other: placebo

Drug: PF-04171327

Primary Outcome(s)

Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria [Time Frame: baseline and week 8]

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]

Secondary Outcome(s)

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]

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 improvement according to ACR hybrid criteria 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]

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]

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 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 50% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe [Time Frame: baseline and Week 2,4,6,8,12]

Secondary ID(s)

A9391010

2010-023782-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors