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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01517620

Enrollment

Registered

2012-01-25

Start date

2011-11-30

Completion date

2012-11-30

Last updated

2013-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

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.

Interventions

DRUGTotal Glucosides Paeony Capsules

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
the proportion of patients which disease activity reaches relapse criteria	24 weeks

Secondary

Measure	Time frame
BASDAI score comparing to baseline	24 weeks
BASFI score comparing to baseline	24 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026