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Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01517620
First received: January 15, 2012
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  Purpose

This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and safety of total glucosides paeony capsules in maintaining clinical remission in patients with ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients will be divided into two groups randomly, one group receive non-steroid anti-inflammatory drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which disease activity reaches relapse criteria. The investigator's hypothesis the proportion of relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID mono-therapy group.


Condition Intervention Phase
Ankylosing Spondylitis
 Drug: Total Glucosides Paeony Capsules
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • the proportion of patients which disease activity reaches relapse criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BASDAI score comparing to baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • BASFI score comparing to baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Total Glucosides Paeony, Capsules Drug: Total Glucosides Paeony Capsules
Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks
No Intervention: no intervention

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged from 16-65 years, sign the Informed Consent
  • Fulfill 1984 modified NewYork classification criteria for AS
  • Achieved clinical remission after at least 12 weeks' therapy of anti-TNF therapy
  • Hb≥9g/dl, ALT/AST≤ 2 folds of upper level normal range, creatine≤120mol/L(≤1.4mg/dl)
  • Commitment to contraceptive for woman

Exclusion Criteria:

  • History of psoriasis and/or inflammatory bowel diseases
  • Receive intra-articular injection of cortisone within 3 months before enrollment
  • History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
  • Pregnant and lactating women
  • Mentally ill, Alcoholics and drug addicts
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517620

Locations
China, Guangdong
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
China
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Sponsors and Collaborators
Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Gu Jieruo, Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01517620     History of Changes
Other Study ID Numbers: [2011]2-38
Study First Received: January 15, 2012
Last Updated: January 24, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 22, 2013