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Trial record 1 of 1 for:    NCT02311842
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To Investigate Genetic Factors Associated With the Response to Anti-TNF Therapy in Patients With Early AS

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ClinicalTrials.gov Identifier: NCT02311842
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University

Tracking Information
First Submitted Date December 4, 2014
First Posted Date December 8, 2014
Last Update Posted Date December 8, 2014
Study Start Date January 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2014)
ASAS20 response [ Time Frame: 12 weeks ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 4, 2014)
  • ASAS40/70 response proportion [ Time Frame: 12 weeks ]
  • ASAS5/6 response proportion [ Time Frame: 12 weeks ]
  • BASDAI50 response proportion [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title To Investigate Genetic Factors Associated With the Response to Anti-TNF Therapy in Patients With Early AS
Official Title To Investigate Genetic Factors Associated With the Response to Anti-TNF Therapy in Patients With Early Ankylosing Spondylitis
Brief Summary Ankylosing spondylitits (AS) is a chronic, systemic rheumatic disease primarily affecting spine and sacroiliac joints, which belongs to the group of conditions known as spondyloarthopathies and causes eventual fusion of the spine. Twin study in AS estimated a heritability of over 90%. HLA-B27 is regarded as the earlist and most important gene associated with AS heritability, and over 90% of AS patients carry HLA-B27 gene. HLA-B27 was highly polymorphic, and more than 89 subtypes of B27 gene have been found. Subtypes of HLA-B27 vary between different regions, and so on as the relationship between HLA-B27 subtypes and disease development among different races. Anti-TNF- agents were regarded as one milestone in recent years development on treatment of ankylosing spondylitis, and most patients showed significant improvement after anti-TNF- therapy. Yet part of patients still showed insufficient response. Our previous study suggested AS patients carrying different genotype of SNP in TNF gene had different response to anti-TNF- therapies. But more studies should be carried out to identified more gene polymorphisms associated with treatment response. In this study we designed a prospective, open-label trial to investigate the genetic difference beween AS patients with different response to anti-TNF- therapy. We plan to enroll 50-100 early AS patients which fulfill the 2009 ASAS axial spondyloarthritis classification criteria and have axial symptom for no more than 2 years. The patients must have high disease activity defined as BASDAI 4, and HLA-B27 test must be positive. The patients should be able to receive 24 weeks of etanercept treatment. And patients who have previous other anti-TNF- therapy and any contraindication of anti-TNF- therapy must be excluded. Other medicines should be stable for at least 4 weeks before etanercept treatment begins. For the clinic assessment, patients should fill in the AS questionaires and receive physical examination at each visit. ASAS20 is thought as the primary endpoint. For the genetic polymorphysm detection, we select 10-20 SNP in MHC region associated with AS and 5-10 HLA-B27 subtypes which have been worked over and have definite association with AS. At the first visit 4ml of anticoagulated blood was collected and DNA was extracted. Target SNPs are detected by PCR then direct sequencing. HLA-B27 subtypes are identified using PCRSSP methods. And the relationship between SNPs/HLA-B27 subtypes and different response to anti TNF- therapy is accessed using chi-square statistic process in SPSS software. In this study we plan to investigate the relationship between genetic background and the clinical response to anti-TNF- therapy in AS patients, which has been seldom reported before. Our group have been studying the disease-associated gene of AS for years, and got plenty of data and experience about genetic study of AS.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Chinese patients with early AS
Condition Ankylosing Spondylitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 4, 2014)
68
Original Actual Enrollment Same as current
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:1.Fulfilled ASAS2009 criterioncriteria; 2.The duration of axial syptoms less than 2 years and in active status before treatment(BASDAI≥4);3.HLA-B27 positive;4.Completed the Etanercept treatment of 12-24 weeks;5. Completed the clinical data and questionnaire rbefore and after of the treatment; 6. Assigend the ICF. Exclusion Criteria:1. Received other anti-TNF-αagents treatment; 2.Patients with other rheumatic disease which may influent gene test and efficacy, including RA, PsA, OA, SLE, etc. 3.Other possible influence factors , including articular cavity local injections of glucocorticoid prior 4 weeks before TNF alpha antagonists treatment;4. Incomplete data.

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Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02311842
Other Study ID Numbers WA1627494
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gu Jieruo, Sun Yat-sen University
Study Sponsor Sun Yat-sen University
Collaborators Pfizer
Investigators
Principal Investigator: Jieruo Gu, MD Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University Guangzhou, Guangdong, China
PRS Account Sun Yat-sen University
Verification Date December 2014