- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00207701
A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.
May 16, 2011 updated by: Centocor, Inc.
A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy
A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis
Study Overview
Detailed Description
This is a clinical research study that will determine if there is a reduction in the signs and symptoms (such as back pain and stiffness) of patients with ankylosing spondylitis with infliximab therapy.
This study will also study the safety of infliximab in patients with ankylosing spondylitis.
The effect of infliximab on physical function, damage to joints and the quality of life in patients with ankylosing spondylitis will also be studied.
Subjects received infusions of either placebo at weeks 0, 2, 6, 12, 18 and 5 mg/kg infliximab at weeks 24, 26, 30 and every 6 weeks through week 96, or 5 mg/kg infliximab at weeks 1, 2, 6, 12, 18 and every 6 weeks through week 96
Study Type
Interventional
Enrollment (Actual)
279
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have had a diagnosis of definite Akylosing Spondylitis for at least 3 months prior to screening
- Have active disease with spinal pain
- receiving or intolerant to standard anti-inflammatory agents
Exclusion Criteria:
- Have Rheumatoid Arthritis, systemic lupus erythematosus, or other inflammatory rheumatic disease
- Have a documented history of fibromyalgia
- Have total ankylosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
|
Secondary Outcome Measures
Outcome Measure |
---|
The change from baseline in BASFI at week 24, the proportion of subjects who achieved an AS major clinical response at week 24, and the change from baseline in the physical component summary score of the SF-36 at week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- van der Heijde D, Han C, DeVlam K, Burmester G, van den Bosch F, Williamson P, Bala M, Han J, Braun J. Infliximab improves productivity and reduces workday loss in patients with ankylosing spondylitis: results from a randomized, placebo-controlled trial. Arthritis Rheum. 2006 Aug 15;55(4):569-74. doi: 10.1002/art.22097.
- Braun J, Landewe R, Hermann KG, Han J, Yan S, Williamson P, van der Heijde D; ASSERT Study Group. Major reduction in spinal inflammation in patients with ankylosing spondylitis after treatment with infliximab: results of a multicenter, randomized, double-blind, placebo-controlled magnetic resonance imaging study. Arthritis Rheum. 2006 May;54(5):1646-52. doi: 10.1002/art.21790.
- van der Heijde D, Dijkmans B, Geusens P, Sieper J, DeWoody K, Williamson P, Braun J; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum. 2005 Feb;52(2):582-91. doi: 10.1002/art.20852.
- Webers C, Stolwijk C, Schiepers O, Schoonbrood T, van Tubergen A, Landewe R, van der Heijde D, Boonen A. Infliximab treatment reduces depressive symptoms in patients with ankylosing spondylitis: an ancillary study to a randomized controlled trial (ASSERT). Arthritis Res Ther. 2020 Sep 29;22(1):225. doi: 10.1186/s13075-020-02305-w.
- Braun J, Deodhar A, Dijkmans B, Geusens P, Sieper J, Williamson P, Xu W, Visvanathan S, Baker D, Goldstein N, van der Heijde D; Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis over a two-year period. Arthritis Rheum. 2008 Sep 15;59(9):1270-8. doi: 10.1002/art.24001.
Helpful Links
- A Randomized, Double-blind Trial of the Efficacy of REMICADE� (Infliximab) Compared with Placebo in Subjects with Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy
- | A Randomized, Double-blind Trial of the Efficacy of REMICADE® (Infliximab) Compared with Placebo in Subjects with Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therap
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
May 17, 2011
Last Update Submitted That Met QC Criteria
May 16, 2011
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004792
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankylosing Spondylitis
-
Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingActive Ankylosing SpondylitisChina
-
AbbVieBoehringer IngelheimCompletedAnkylosing Spondylitis (AS)
-
Sun Yat-sen UniversityUnknownEarly Ankylosing Spondylitis
-
AbbVieCompletedAnkylosing Spondylitis (AS)United States, Australia, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, United Kingdom
-
Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineRecruitingAnkylosing Spondylitis (AS)China
-
Chinese University of Hong KongCompletedAnkylosing Spondylitis(AS)China
-
AbbVieCompletedAnkylosing Spondylitis (AS)Taiwan
-
Tianjin Hemay Pharmaceutical Co., LtdCompletedActive Ankylosing SpondylitisChina
-
Jiangsu vcare pharmaceutical technology co., LTDRecruitingActive Ankylosing SpondylitisChina
-
Assiut UniversityUnknownActive Sacroiliitis in Ankylosing Spondylitis
Clinical Trials on infliximab
-
Onze Lieve Vrouwe GasthuisSanteonUnknown
-
Merck Sharp & Dohme LLCIntegrated Therapeutics GroupTerminatedRheumatoid Arthritis
-
PfizerCompleted
-
Diakonhjemmet HospitalSouth-Eastern Norway Regional Health AuthorityCompletedRheumatoid Arthritis | Crohn's Disease | Ulcerative Colitis | Psoriatic Arthritis | Spondyloarthritis | Psoriasis ChronicNorway
-
Centre hospitalier de l'Université de Montréal...Ottawa Hospital Research Institute; Maisonneuve-Rosemont Hospital; Niagara Health... and other collaboratorsRecruiting
-
NYU Langone HealthWithdrawnInflammatory Bowel Disease
-
PfizerCompletedPsoriasis Vulgaris | Pustular Psoriasis | Psoriasis Arthropathica | Erythrodermic PsoriasisJapan
-
European Organisation for Research and Treatment...CompletedMyelodysplastic SyndromesFrance, Belgium, Netherlands, Czech Republic, Italy, Germany
-
Janssen Research & Development, LLCJanssen Biologics BVCompletedUlcerative ColitisUnited States, France, United Kingdom, Belgium, Switzerland, Israel, Canada, Australia, Netherlands, New Zealand, Austria, Germany, Denmark, Czechia, Argentina
-
BiocadCompletedAnkylosing SpondylitisRussian Federation, Belarus