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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01709656 |
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Date of registration:
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10/10/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis
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Scientific title:
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A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01709656 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Jieruo Gu, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Rheumatology , Third Affiliated Hospital of Sun Yat-sen University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Aged from 16-65 years, sign the Informed Consent
2. Fulfill 1984 modified NewYork classification criteria for AS
3. Have an active refractory disease defined by a score =40 on the Bath AS Disease
Activity Index (BASDAI) (0-100) despite optimal non-steroidal anti-inflammatory drug
(NSAID) treatment.
4. Commitment to contraceptive for woman
Exclusion Criteria:
1. Completely stiff spine
2. Received spinal or joint surgery within 2 months
3. Received anti-TNF therapy within 3 months
4. History of the listed diseases: heart failure, Multiple sclerosis, severe chronic
obstructive pulmonary disease, frequent infections, lymphoma or other cancers,
tuberculosis
5. Female of pregnancy or breast feeding
6. Hb= 9g/dl for male or Hb = 8.5 g/dl for male, ALT/AST=2folds of upper level normal
range, Creatine=120mol/L(=1.4mg/dl)
Age minimum:
16 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Biological: MSC
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Drug: "celecoxib", "Celebrex®"
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Primary Outcome(s)
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the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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BASDAI score comparing to baseline
[Time Frame: 24 weeks]
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BASFI score comparing to baseline
[Time Frame: 24 weeks]
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Secondary ID(s)
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[2012]2-31
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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