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Ankylosing SpondylitisNCT02311842

To Investigate Genetic Factors Associated With the Response to Anti-TNF Therapy in Patients With Early AS

An observational study of Ankylosing Spondylitis, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ankylosing Spondylitis
How many people
68 participants
Where
1 siteChina
Study dates
Jan 2012to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chinese patients with early AS

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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Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: To Investigate Genetic Factors Associated With the Response to Anti-TNF Therapy in Patients With Early Ankylosing Spondylitis

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.

Medical subject headings
Spondylitis, Ankylosing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ASAS20 response

    Measured: 12 weeks

Secondary outcomes (3)

  1. ASAS40/70 response proportion

    Measured: 12 weeks

  2. ASAS5/6 response proportion

    Measured: 12 weeks

  3. BASDAI50 response proportion

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2014 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02311842
Sponsor's protocol ID
WA1627494
Status last verified
Dec 2014
First submitted
4 Dec 2014
Last updated
8 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • van der Linden S, Valkenburg H, Cats A. The risk of developing ankylosing spondylitis in HLA-B27 positive individuals: a family and population study. Br J Rheumatol. 1983 Nov;22(4 Suppl 2):18-9. doi: 10.1093/rheumatology/xxii.suppl_2.18.

    PubMed 6606472

  • Brown MA, Kennedy LG, MacGregor AJ, Darke C, Duncan E, Shatford JL, Taylor A, Calin A, Wordsworth P. Susceptibility to ankylosing spondylitis in twins: the role of genes, HLA, and the environment. Arthritis Rheum. 1997 Oct;40(10):1823-8. doi: 10.1002/art.1780401015.

    PubMed 9336417

  • Tam LS, Gu J, Yu D. Pathogenesis of ankylosing spondylitis. Nat Rev Rheumatol. 2010 Jul;6(7):399-405. doi: 10.1038/nrrheum.2010.79. Epub 2010 Jun 1.

    PubMed 20517295

  • Gratacos J, Collado A, Filella X, Sanmarti R, Canete J, Llena J, Molina R, Ballesta A, Munoz-Gomez J. Serum cytokines (IL-6, TNF-alpha, IL-1 beta and IFN-gamma) in ankylosing spondylitis: a close correlation between serum IL-6 and disease activity and severity. Br J Rheumatol. 1994 Oct;33(10):927-31. doi: 10.1093/rheumatology/33.10.927.

    PubMed 7921752

  • Braun J, Bollow M, Neure L, Seipelt E, Seyrekbasan F, Herbst H, Eggens U, Distler A, Sieper J. Use of immunohistologic and in situ hybridization techniques in the examination of sacroiliac joint biopsy specimens from patients with ankylosing spondylitis. Arthritis Rheum. 1995 Apr;38(4):499-505. doi: 10.1002/art.1780380407.

    PubMed 7718003

  • Carter KW, Pluzhnikov A, Timms AE, Miceli-Richard C, Bourgain C, Wordsworth BP, Jean-Pierre H, Cox NJ, Palmer LJ, Breban M, Reveille JD, Brown MA. Combined analysis of three whole genome linkage scans for Ankylosing Spondylitis. Rheumatology (Oxford). 2007 May;46(5):763-71. doi: 10.1093/rheumatology/kel443. Epub 2007 Jan 27.

    PubMed 17259653

Questions about this trial

What is this clinical trial studying?

An observational study of Ankylosing Spondylitis, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ASAS20 response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02311842, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.

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