Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study
CERTAIN
A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis
2 other identifiers
interventional
194
5 countries
31
Brief Summary
To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started Jun 2008
31 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
First Submitted
Initial submission to the registry
May 5, 2008
CompletedFirst Posted
Study publicly available on registry
May 7, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
January 18, 2012
CompletedJanuary 18, 2012
December 1, 2011
1.9 years
May 5, 2008
December 9, 2011
December 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)
Week 20 and Week 24
Secondary Outcomes (22)
28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24
Week 20 and Week 24
Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24
Week 20 and Week 24
Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits
Week 24 up to Week 52
Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits
Week 24 up to Week 52
Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits
Week 24 up to Week 52
- +17 more secondary outcomes
Other Outcomes (7)
Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits
From Week 24 up to Week 52
Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24
Week 24
Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24
Week 24
- +4 more other outcomes
Study Arms (2)
Certolizumab pegol 200 mg (CDP870)
EXPERIMENTALTwo 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Placebo
PLACEBO COMPARATORTwo 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Interventions
Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Eligibility Criteria
You may qualify if:
- Patients with established diagnosis of low to moderate adult rheumatoid arthritis, currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six months and not longer than 10 years
You may not qualify if:
- All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
- Patients must not have received any previous biological therapy for rheumatoid arthritis (RA)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (31)
Unknown Facility
Graz, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Nantes, France
Unknown Facility
Paris, France
Unknown Facility
Rennes, France
Unknown Facility
Rouen, France
Unknown Facility
Tours, France
Unknown Facility
Bad Nauheim, Germany
Unknown Facility
Berlin, Germany
Unknown Facility
Erlangen, Germany
Unknown Facility
Essen, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Herne, Germany
Unknown Facility
Ratingen, Germany
Unknown Facility
Vogelsang-Gom, Germany
Unknown Facility
Würzburg, Germany
Unknown Facility
Ferrara, Italy
Unknown Facility
Padua, Italy
Unknown Facility
Pavia, Italy
Unknown Facility
Roma, Italy
Unknown Facility
Bialystok, Poland
Unknown Facility
Bydgoszcz, Poland
Unknown Facility
Elblag, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Sopot, Poland
Unknown Facility
Szczecin, Poland
Unknown Facility
Torun, Poland
Unknown Facility
Wroclaw, Poland
Related Publications (1)
Smolen JS, Emery P, Ferraccioli GF, Samborski W, Berenbaum F, Davies OR, Koetse W, Purcaru O, Bennett B, Burkhardt H. Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial. Ann Rheum Dis. 2015 May;74(5):843-50. doi: 10.1136/annrheumdis-2013-204632. Epub 2014 Jan 15.
PMID: 24431394DERIVED
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 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2008
First Posted
May 7, 2008
Study Start
June 1, 2008
Primary Completion
May 1, 2010
Study Completion
December 1, 2010
Last Updated
January 18, 2012
Results First Posted
January 18, 2012
Record last verified: 2011-12