A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis
NCT ID: NCT01709656
Last Updated: 2015-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
120 participants
INTERVENTIONAL
2012-03-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
NCT02705989
Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis
NCT02456363
A Study of CC-99677 in Participants With Active Ankylosing Spondylitis
NCT04947579
A Clinical Study of JS005 in Patients With Ankylosing Spondylitis
NCT06250062
Efficacy and Safety of SCT650C in Participants With Axial Spondyloarthritis
NCT06197009
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MSC plus NSAID
human mesenchymal stem cells:1\*10\^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment, plus non-steroid anti-inflammatory drugs (NSAID: "celecoxib", "Celebrex®" 0.2g Bid(twice a day),PO (Per Os).
Duration of treatment:24 weeks for follow up. collect peripheral blood (PBMCs and serums)of those patients at baseline and every 4 weeks for basic study after they signed informed consent.
MSC
human mesenchymal stem cells,1\*10\^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment.
a total of 24 weeks for follow up.
"celecoxib", "Celebrex®"
non-steroid anti-inflammatory drugs (NSAID):"celecoxib", "Celebrex®" 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up
NSAID
non-steroid anti-inflammatory drugs (NSAID: "celecoxib", "Celebrex®" 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up;collect peripheral blood (PBMCs and serums)of those patients at baseline and every 4 weeks for basic study after they signed informed consent.
"celecoxib", "Celebrex®"
non-steroid anti-inflammatory drugs (NSAID):"celecoxib", "Celebrex®" 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MSC
human mesenchymal stem cells,1\*10\^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment.
a total of 24 weeks for follow up.
"celecoxib", "Celebrex®"
non-steroid anti-inflammatory drugs (NSAID):"celecoxib", "Celebrex®" 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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)
16 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gu Jieruo
Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jieruo Gu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Rheumatology , Third Affiliated Hospital of Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
[2012]2-31
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.