A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department (ENBREL NIS CN)
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01411215
First received: May 13, 2011
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
This is an open-label, multicenter and observational study in China, which is designed to record the data of RA & AS patients within 52 weeks after rheumatologists decided to prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible subjects agreed to be recruited in the study and can withdraw anytime if they choose so.
Patients with RA or AS are typically managed by rheumatologists. As this study seeks to record the data of RA & AS patient in etanercept and evaluate the safety and efficacy of the treatment, patients will be recruited from Rheumatic department. Rheumatologist will be asked to build up the database for RA & AS patient surveillance prospectively in outpatient dept, which benefits for the patient treatment outcomes evaluation and clinical management.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Ankylosing Spondylitis |
Drug: Enbrel |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department |
Resource links provided by NLM:
Genetics Home Reference related topics:
ankylosing spondylitis
Drug Information available for:
Etanercept
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Evaluate the safety of etanercept in real clinical practice in Chinese RA and AS subjects by measuring the number of subjects reporting an event [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluate the efficacy of etanercept in Chinese RA and AS subjects by comparing Disease Activity Score Using 28-Joint Count (DAS28) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Evaluate the efficacy of etanercept in Chinese RA and AS subjects by comparing the Physician Global Assessment (PGA) of Disease Activity on 0-100 mm visual analog scale (VAS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Evaluate the efficacy of etanercept in Chinese RA and AS subjects by comparing the Pain assessment 0-100 mm visual analog scale (VAS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Evaluate the subject's adherence to treatment in real-life by comparing patient's dosage and frequency with label use (25 mg biweekly, or 50 mg weekly) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Evaluate the association between subject's age and treatment adherence by comparing grouped adherence [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 166 |
| Study Start Date: | January 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
RA, AS
Rheumatoid arthritis patients Ankylosing spondylitis patients
|
Drug: Enbrel
25mg biweekly or 50mg per week, subcutaneous injection
Other Name: etanercept
|
Detailed Description:
The primary objective of this non-interventional study is to evaluate the safety of etanercept in Chinese RA and AS subjects. Total of 600 subjects (300 RA subjects and 300 AS subjects) will be enrolled in the study. If the true rate of an adverse event is no less than 0.5%, with sample size of 600 subjects, this study will have 95% probability to detect at least one occurrence of the adverse event. The study prematurely discontinued on January 15, 2013 due to slow enrollment and low adherence of etanercept. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
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
outpatient RA and AS patients in China
Criteria
Inclusion Criteria:
- Subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis.
- Subject has accepted physician's prescription of etanercept in rheumatology department.
- Subject agreed to be enrolled in the observational study and sign the ICD.
- Subject is≥18 years of age at the time of consent.
- Subject is willing and able to understand and complete questionnaires
Exclusion Criteria:
- Presence of active or suspected latent infection including HIV, or any underlying disease, including open cutaneous ulcers that could predispose the subject to infections.
- Immunodeficiency syndromes including Felty syndrome or large granular lymphocyte syndrome.
- Active tuberculosis (TB) or a history of TB, or findings consistent with previous exposure to TB on a chest x-ray (CXR). Investigators must follow China's guidelines for appropriate screening and treatment of TB.
- History of hypersensitivity to any of the ingredients in either preparation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411215
Locations
| China, Chongqing | |
| Daping Hospital | |
| Chongqing, Chongqing, China, 400038 | |
| China, Fujian | |
| Fujian Provincial Hospital | |
| Fuzhou, Fujian, China, 350001 | |
| China, Gansu | |
| Lanzhou University Second Hospital | |
| Lanzhou, Gansu, China, 730030 | |
| China, Guangdong | |
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | |
| Guangzhou, Guangdong, China, 510405 | |
| China, Heilongjiang | |
| No. 199 | |
| Haerbin, Heilongjiang, China, 150001 | |
| China, Hunan | |
| The Second Xiangya Hospital of Central South University | |
| Changsha, Hunan, China, 410011 | |
| China, Inner Mongolia | |
| The First Affiliated Hospital of Baotou Medical College | |
| Baotou, Inner Mongolia, China, 014010 | |
| China, Jiangsu | |
| Jiangsu Province Hospital/Department of Rheumatology | |
| Nanjing, Jiangsu, China, 210029 | |
| Affiliated Hospital of Nantong University | |
| Nantong, Jiangsu, China, 226001 | |
| China, Shanxi | |
| The Second Hospital of Shanxi Medical University | |
| Taiyuan, Shanxi, China, 030001 | |
| China, Sichuan | |
| Si Chuan Huaxi Hospital/Rheumatology Department | |
| Chengdu, Sichuan, China, 610041 | |
| China | |
| Baotou Central Hospital | |
| Baotou city, China | |
| Shanghai Changning Guanghua Integrative Medicine Hospital | |
| Beijing, China, 200052 | |
| Shanghai Jiaotong University Affiliated Third People's Hospital | |
| Shanghai, China, 201900 | |
| Xinjiang Uygur Autonomous Region People's Hospital | |
| Urumqi, China, 830001 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01411215 History of Changes |
| Other Study ID Numbers: | B1801044 |
| Study First Received: | May 13, 2011 |
| Last Updated: | March 4, 2013 |
| Health Authority: | China: People's hospital |
Keywords provided by Pfizer:
|
Rheumatoid arthritis ankylosing spondylitis observational study |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Bone Diseases Spinal Diseases Spondylarthropathies |
Spondylarthritis Ankylosis TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013