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NCT02996500 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
A Phase 2 study of Rheumatoid Arthritis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 269
- Enrollment target
- 20
- Study locations
NCT02996500: Completed Phase 2 study of Rheumatoid Arthritis, sponsored by Pfizer.
NCT02996500 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Pfizer. The registered enrollment target is 269 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02996500, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 269 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to MTX. PF-06650833 or matching placebo tablets will be administered orally QD under fasting conditions, and tofacitinib or matching tofacitinib placebo tablets will be administered orally BID for 12 weeks in a blinded fashion.
Primary Outcome
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 cm scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL). SDAI total score= 0-86. SDAI
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tofacitinib
- DRUG PF-06650833
Study Locations (20)
Florida
- Robert W. Levin, MD,PA - Clearwater
- Millennium Research - Ormond Beach
- Arthritis & Rheumatic Care Center - South Miami
- Qps-Mra, Llc - South Miami
Texas
- Accurate Clinical Management, LLC - Baytown
- Accurate Clinical Management, LLC - Houston
- Accurate Clinical Management, LLC - Houston
- DM Clinical Research - Tomball
Arizona
- Dory Hardy, PharmD - Tucson
- Southern Arizona VA Health care System - Tucson
Republika Srpska
- University Clinical Center Republic of Srpska - Banja Luka
- Health Center Gradiska - Gradiška
Alabama
- Clinical and Translational Research Center of Alabama, PC - Tuscaloosa
Georgia
- Medical Associates of North Georgia - Canton
Kentucky
- Graves Gilbert Clinic - Bowling Green
Louisiana
- Arthritis and Diabetes Clinic, Inc. - Monroe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2016-11-10 |
| Est. Completion | 2018-08-15 |
| Phase | Phase 2 |
What the finished NCT02996500 record still lists
NCT02996500 is an interventional study that assigns participants to a tested intervention. The registered 269 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02996500 names 20 study sites across 12 states, led by Florida, Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT02996500 about?
NCT02996500 is a clinical study titled "Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate". This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to MTX. PF-06650833 or matching pla...
What is the current status of trial NCT02996500?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 269 participants. The study started on 2016-11-10. Estimated completion is 2018-08-15.
What conditions does trial NCT02996500 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT02996500?
The interventions under investigation include: Placebo (DRUG), Tofacitinib (DRUG), PF-06650833 (DRUG).
Who is sponsoring clinical trial NCT02996500?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02996500 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02996500's enrollment target sits among peer trials
269 67th of 197 higher than 131 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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