- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00936143
Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis
January 24, 2016 updated by: Gu Jieruo
An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis
This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS).
Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg.
The major outcome index is ASAS20, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70.
And MRI of sacroiliac joint is not necessary.
The adverse events at any time were recorded.
Study Overview
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510630
- Third Affiliated Hospital of Sun Yat-sen University
-
-
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
16 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 16 to 65 years old, having signed the informed consent;
- fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
- have inflammatory back pain defined by Calin criteria;
- disease duration range from 6 months to 2 years;
- BASDAI score more than 4;
- MRI score of sacroiliac joint more than 4;
- lab examination: hemoglobin more than 90 gram/liter. Aspartate aminotransferase and Alanine aminotransferase less than 2 fold of upper level of normal range. Creatine less than upper level of normal range.
Exclusion Criteria:
- History of psoriasis or inflammatory bowel disease.
- Intra-articular injection of cortisone within 3 months.
- Patients were taking cortisone, SASP or MTX, unless the dose has been stable for at least 3 months.
- Active iritis.
- History of heart failure, multiple sclerosis, COPD, lymphoma or other tumor, tuberculosis.
- Female of pregnancy or breast feeding.
- History of mental disease and poor compliance.
- History of drug abuse or alcoholism.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: infliximab
200mg infliximab inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
|
100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients achieving ASAS20 improvement.
Time Frame: 6th week
|
6th week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients achieving ASAS50 and ASAS70
Time Frame: 6th week and 24 week.
|
6th week and 24 week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
July 7, 2009
First Submitted That Met QC Criteria
July 8, 2009
First Posted (Estimate)
July 9, 2009
Study Record Updates
Last Update Posted (Estimate)
January 26, 2016
Last Update Submitted That Met QC Criteria
January 24, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REM-CHN-IIS-01
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 Spondylitis
-
Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingActive Ankylosing SpondylitisChina
-
AbbVieBoehringer IngelheimCompletedAnkylosing Spondylitis (AS)
-
Sun Yat-sen UniversityUnknownEarly Ankylosing Spondylitis
-
Novartis PharmaceuticalsCompletedAnklyosing SpondylitisGermany, Austria, Spain, Switzerland, United Kingdom, United States, Singapore, Russian Federation, Netherlands, Italy, Finland, Czechia, Canada
-
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
-
AbbVieCompletedAnkylosing Spondylitis (AS)Taiwan
-
Tianjin Hemay Pharmaceutical Co., LtdCompletedActive Ankylosing SpondylitisChina
-
Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineRecruitingAnkylosing Spondylitis (AS)China
-
Chinese University of Hong KongCompletedAnkylosing Spondylitis(AS)China
-
Ankara City Hospital BilkentRecruitingAxial Spondyloarthritis and Ankylosing SpondylitisTurkey
Clinical Trials on infliximab
-
Onze Lieve Vrouwe GasthuisSanteonUnknown
-
Merck Sharp & Dohme LLCIntegrated Therapeutics GroupTerminatedRheumatoid Arthritis
-
Diakonhjemmet HospitalSouth-Eastern Norway Regional Health AuthorityCompletedRheumatoid Arthritis | Crohn's Disease | Ulcerative Colitis | Psoriatic Arthritis | Spondyloarthritis | Psoriasis ChronicNorway
-
PfizerCompleted
-
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
-
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
-
European Organisation for Research and Treatment...CompletedMyelodysplastic SyndromesFrance, Belgium, Netherlands, Czech Republic, Italy, Germany