Dosing Flexibility Study in Patients With Rheumatoid Arthritis
DoseFlex
A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.
2 other identifiers
interventional
333
3 countries
66
Brief Summary
During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 rheumatoid-arthritis
Started Dec 2007
Typical duration for phase_4 rheumatoid-arthritis
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
December 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
March 19, 2012
CompletedAugust 2, 2018
March 1, 2012
3 years
December 21, 2007
December 14, 2011
July 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Baseline, Week 34
Secondary Outcomes (35)
Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients
Baseline, Week 16
Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients
Baseline, Week 16
Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients
Baseline, Week 16
Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients
Baseline, Week 16
Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients
Baseline, Week 16
- +30 more secondary outcomes
Other Outcomes (5)
Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients
Baseline, Week 16
Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18
Baseline, Week 34
Change From Baseline in PhGADA (Physician's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18
Baseline, Week 34
- +2 more other outcomes
Study Arms (3)
Certolizumab pegol 400 mg and placebo
ACTIVE COMPARATOR400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
Certolizumab pegol 200 mg and placebo
EXPERIMENTAL200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each)
Placebo
PLACEBO COMPARATORPlacebo administered as two injections every 2 weeks
Interventions
400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks)
placebo (saline) administered as two injections every 2 weeks
Eligibility Criteria
You may qualify if:
- Patients with established adult rheumatoid arthritis currently on Methotrexate for at least 3 months
You may not qualify if:
- All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
- Previous clinical trials participation and previous biological therapy that could interfere with the results of the present clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (66)
Unknown Facility
Huntsville, Alabama, United States
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Montgomery, Alabama, United States
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Gilbert, Arizona, United States
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Paradise Valley, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Palm Desert, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Aventura, Florida, United States
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Melbourne, Florida, United States
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Sarasota, Florida, United States
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Bogart, Georgia, United States
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Morton Grove, Illinois, United States
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Vernon Hills, Illinois, United States
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Lexington, Kentucky, United States
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Portland, Maine, United States
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Haverhill, Massachusetts, United States
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Pittsfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Rochester, Minnesota, United States
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Kansas City, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Albany, New York, United States
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Mineola, New York, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Monroe, North Carolina, United States
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Wilmington, North Carolina, United States
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Cleveland, Ohio, United States
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Perrysburg, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Duncansville, Pennsylvania, United States
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Simpsonville, South Carolina, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Tyler, Texas, United States
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Vancouver, Washington, United States
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Burlington, Ontario, Canada
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Saint Catherine's, Ontario, Canada
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Toronto, Ontario, Canada
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Saskatoon, Saskatchewan, Canada
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Bobigny, France
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Le Havre, France
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Lille, France
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Limoges, France
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Montivilliers, France
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Nice, France
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Paris, France
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Perpigan, France
Unknown Facility
Saint-Etienne, France
Related Publications (1)
Furst DE, Shaikh SA, Greenwald M, Bennett B, Davies O, Luijtens K, Staelens F, Koetse W, Bertin P. Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):151-60. doi: 10.1002/acr.22496.
PMID: 25302624DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 21, 2007
First Posted
December 27, 2007
Study Start
December 1, 2007
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
August 2, 2018
Results First Posted
March 19, 2012
Record last verified: 2012-03