16.0040 Ankylosing Spondylitis Study
This study has been completed.
Sponsor:
Amgen
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00356356
First received: July 24, 2006
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis |
Drug: Etanercept |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037 |
Resource links provided by NLM:
Genetics Home Reference related topics:
ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
Drug Information available for:
Etanercept
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Treatment Response (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in at least 3 of the 4 domains [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Absence of deterioration (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in the potential remaining ASAS domain [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- DXA and MRI scans (at selected sites) [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
- X-rays of cervical spine and lumbosacral spine [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Type and grade of toxicities [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- ASAS Response Criteria at weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, and the ASAS Response Criteria at 50% and 70% levels at weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 144. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Frequency and time to partial remission as defined in Anderson, 2001: Value of <20 (on a scale of 0-100) in each of the following 4 domains: VAS Patient Global Assessment, VAS Pain Score, BASFI, and BASDAI morning stiffness-related scores [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
- Complete joint assessment [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
- Laboratory assessment of inflammation using CRP [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
- Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
| Enrollment: | 257 |
| Study Start Date: | April 2002 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: All subjects
257 subjects
|
Drug: Etanercept
Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites
|
Detailed Description:
This multicenter, open-label extension study will evaluate the safety and clinical benefit of etanercept in the treatment of Ankylosing Spondylitis in subjects previously enrolled in Protocol 16.0037.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: - Subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study Other patients to meet the following criteria:
- Negative pregnancy test
- Subjects agree to use appropriate contraception throughout study
- Should be able to self-inject study drug or have someone who can do so
- Capable of understanding protocol and willing to provide written informed consent
Exclusion Criteria:
- Any change in NSAID or prednisone dose within 2 weeks of baseline
- Any change in hydroxychloroquine, sulfasalazine, or MTX dose within 4 weeks of baseline
- Use of DMARDs other than those mentioned above, within 4 weeks of enrollment
- Previous receipt of ani-TNF agents, other than etanercept
- Receipt of any other investigational drug within 30 days of baseline
- Grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed
- Abnormality in chemistry or hematology profiles or significant concurrent medical events.
Contacts and Locations More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00356356 History of Changes |
| Other Study ID Numbers: | 20021640, 016.0040 |
| Study First Received: | July 24, 2006 |
| Last Updated: | May 10, 2013 |
| Health Authority: | Canada: Health Canada Europe: EMEA United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis 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 Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013