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| Sponsored by: |
UCB |
|---|---|
| Information provided by: | UCB |
| ClinicalTrials.gov Identifier: | NCT00674362 |
Purpose
To assess the clinical efficacy and safety of Certolizumab as add-on therapy with stable-dose DMARDs for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Certolizumab pegol Other: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis |
| Estimated Enrollment: | 170 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CDP870: Experimental
Certolizumab pegol
|
Drug: Certolizumab pegol
400 mg at W0, W2, W4 200 mg Q2W
|
| Placebo: Placebo Comparator |
Other: Placebo
Saline 0.9%
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: UCB Clinical Trial Call Center | 1 877 822 9493 |
| Austria | |
| Recruiting | |
| Graz, Austria | |
| Recruiting | |
| Klagenfurt, Austria | |
| Recruiting | |
| Wien, Austria | |
| France | |
| Recruiting | |
| Nantes, France | |
| Recruiting | |
| Boulogne, France | |
| Recruiting | |
| Echirolles, France | |
| Recruiting | |
| Bordeaux, France | |
| Recruiting | |
| Paris, France | |
| Recruiting | |
| Rennes, France | |
| Recruiting | |
| Rouen, France | |
| Recruiting | |
| Strasbourg, France | |
| Withdrawn | |
| Toulouse, France | |
| Recruiting | |
| Tours, France | |
| Germany | |
| Recruiting | |
| Bad Bramstedt, Germany | |
| Recruiting | |
| Bad Nauheim, Germany | |
| Recruiting | |
| Berlin, Germany | |
| Recruiting | |
| Erlangen, Germany | |
| Recruiting | |
| Frankfurt, Germany | |
| Recruiting | |
| Hannover, Germany | |
| Withdrawn | |
| Regensburg, Germany | |
| Recruiting | |
| Herne, Germany | |
| Recruiting | |
| Ratingen, Germany | |
| Recruiting | |
| Heidelberg, Germany | |
| Recruiting | |
| Vogelsang-Gom, Germany | |
| Recruiting | |
| Wurzburg, Germany | |
| Recruiting | |
| Essen, Germany | |
| Italy | |
| Recruiting | |
| Ferrara, Italy | |
| Recruiting | |
| Roma, Italy | |
| Recruiting | |
| Pavia, Italy | |
| Recruiting | |
| Padova, Italy | |
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
| Responsible Party: | UCB ( Study Director ) |
| Study ID Numbers: | C87076, Eudract number: 2007-000828-40 |
| Study First Received: | May 5, 2008 |
| Last Updated: | August 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00674362 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Rheumatoid Arthritis Moderate to Low Disease activity Certolizumab pegol |
|
Immunoglobulin Fab Fragments Antibodies Autoimmune Diseases Immunologic Factors Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Immunoglobulins |
|
Immunoglobulin Fab Fragments Autoimmune Diseases Immunologic Factors Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Physiological Effects of Drugs Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Pharmacologic Actions |
