Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (RA) and Crohn's Disease (CD)
This study is currently recruiting participants.
Verified March 2013 by UCB, Inc.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01577264
First received: April 11, 2012
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.
| Condition |
|---|
|
Rheumatoid Arthritis Crohn's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Study to Evaluate the Safety and Effectiveness of Cimzia in Rheumatoid Arthritis and Crohn's Disease Patients When Using a Comprehensive Program of Tuberculosis Screening and Monitoring |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
Drug Information available for:
Certolizumab pegol
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Number of subjects with a Tuberculosis infection during the Study Period of at least 3 years [ Time Frame: Over the whole Study Period of 3 years from Baseline to the last Visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 26 [ Time Frame: At Visit 2 (Week 26) ] [ Designated as safety issue: No ]
- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 52 [ Time Frame: At Visit 3 (Week 52) ] [ Designated as safety issue: No ]
- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 78 [ Time Frame: At Visit 4 (Week 78) ] [ Designated as safety issue: No ]
- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 104 [ Time Frame: At Visit 5 (Week 104) ] [ Designated as safety issue: No ]
- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 130 [ Time Frame: At Visit 6 (Week 130) ] [ Designated as safety issue: No ]
- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 156 [ Time Frame: At Visit 7 (Week 156) ] [ Designated as safety issue: No ]
- Harvey Bradshaw Index (HBI) at Week 26 [ Time Frame: At Visit 2 (Week 26) ] [ Designated as safety issue: No ]
- Harvey Bradshaw Index (HBI) at Week 52 [ Time Frame: At Visit 3 (Week 52) ] [ Designated as safety issue: No ]
- Harvey Bradshaw Index (HBI) at Week 78 [ Time Frame: At Visit 4 (Week 78) ] [ Designated as safety issue: No ]
- Harvey Bradshaw Index (HBI) at Week 104 [ Time Frame: At Visit 5 (Week 104) ] [ Designated as safety issue: No ]
- Harvey Bradshaw Index (HBI) at Week 130 [ Time Frame: At Visit 6 (Week 130) ] [ Designated as safety issue: No ]
- Harvey Bradshaw Index (HBI) at Week 156 [ Time Frame: At Visit 7 (Week 156) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cimzia treatment |
Detailed Description:
This is a prospective non interventional study. Patients enrolled in this study will receive Cimzia on prescription according to the instructions for use approved in Russia and within the frame of current standard clinical practices. The patient is evaluated at the Screening Visit for enrollment. A Baseline Visit is to be scheduled no more than 28 days after the Screening Visit. Subsequent evaluations are done routinely every 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients from previous UCB sponsored studies and all patients for whom the treating physician prescribed Cimzia.
Criteria
Inclusion Criteria:
- Patients who have been prescribed Cimzia
Exclusion Criteria:
- Any contra-indication according to the Russian Summary of Product Characteristic
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577264
Contacts
| Contact: UCB Clinical Trial Call Center | +1 877 822 9493 |
Locations
| Russian Federation | |
| 13 | Recruiting |
| Ekaterinburg, Russian Federation | |
| 28 | Recruiting |
| Ekaterinburg, Russian Federation | |
| 12 | Recruiting |
| Kazan, Russian Federation | |
| 16 | Recruiting |
| Kazan, Russian Federation | |
| 5 | Recruiting |
| Moscow, Russian Federation | |
| 7 | Recruiting |
| Moscow, Russian Federation | |
| 8 | Recruiting |
| Moscow, Russian Federation | |
| 9 | Recruiting |
| Moscow, Russian Federation | |
| 11 | Recruiting |
| Moscow, Russian Federation | |
| 14 | Recruiting |
| Moscow, Russian Federation | |
| 24 | Recruiting |
| Moscow, Russian Federation | |
| 25 | Recruiting |
| Moscow, Russian Federation | |
| 31 | Recruiting |
| Moscow, Russian Federation | |
| 23 | Recruiting |
| Novgorod, Russian Federation | |
| 20 | Recruiting |
| Orenburg, Russian Federation | |
| 21 | Recruiting |
| Orenburg, Russian Federation | |
| 29 | Recruiting |
| Orenburg, Russian Federation | |
| 1 | Recruiting |
| Saint Petersburg, Russian Federation | |
| 3 | Recruiting |
| Saint Petersburg, Russian Federation | |
| 4 | Recruiting |
| Saint Petersburg, Russian Federation | |
| 6 | Recruiting |
| Saint Petersburg, Russian Federation | |
| 15 | Recruiting |
| Samara, Russian Federation | |
| 18 | Recruiting |
| Samara, Russian Federation | |
| 17 | Recruiting |
| Shakhty, Russian Federation | |
| 19 | Recruiting |
| St. Petersburg, Russian Federation | |
| 10 | Recruiting |
| Taganrog, Russian Federation | |
| 26 | Recruiting |
| Tolyatti, Russian Federation | |
| 22 | Recruiting |
| Ufa, Russian Federation | |
| 27 | Recruiting |
| Ufa, Russian Federation | |
| 32 | Recruiting |
| Ufa, Russian Federation | |
| 30 | Recruiting |
| Ulyanovsk, Russian Federation | |
| 2 | Recruiting |
| Yaroslavl, Russian Federation | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01577264 History of Changes |
| Other Study ID Numbers: | RA0091 |
| Study First Received: | April 11, 2012 |
| Last Updated: | March 25, 2013 |
| Health Authority: | Russia: Ministry of Health of the Russian Federation |
Keywords provided by UCB, Inc.:
|
Certolizumab Pegol Cimzia |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Crohn Disease Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013