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

NCT01517620 | Completed Phase 4 DMC

• 1 other identifier: [2011]2-38
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• the proportion of patients which disease activity reaches relapse criteria

  24 weeks

Secondary Outcomes (2)

• BASDAI score comparing to baseline

  24 weeks

• BASFI score comparing to baseline

  24 weeks

Study Arms (2)

Total Glucosides Paeony, Capsules

EXPERIMENTAL

Drug: Total Glucosides Paeony Capsules

no intervention

NO INTERVENTION

Interventions

Total Glucosides Paeony Capsules DRUG

Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks

Total Glucosides Paeony, Capsules

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

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

Guangzhou, Guangdong, 510630, China

Location

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

Guangzhou, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: January 15, 2012
• First Posted: January 25, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

CN (2)