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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

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ClinicalTrials.gov Identifier: NCT01517620
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Total Glucosides Paeony Capsules Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2011
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. the proportion of patients which disease activity reaches relapse criteria [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. BASDAI score comparing to baseline [ Time Frame: 24 weeks ]
  2. BASFI score comparing to baseline [ Time Frame: 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013

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