Sequential Application of Yisaipu® and DMARDs in Treating Mild-to-Moderate AS

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: Yisaipu®

Study type: Interventional

Funder types: Other

Identifiers

NCT03411798

NFEC-201711-K6

Details and patient eligibility

About

The drug regimes in treating ankylosing spondylitis(AS) have limitations. The tumor necrosis factor inhibitors(TNFi) was effective but expensive. Disease modifying anti-rheumatic drugs (DMARDs) were cheap but insufficient. This study proposed a sequential usage of TNFi, the Yisaipu®, and DMARDs, and aims to evaluate the mid-term therapeutic effect of this new scheme in treating the mild-to-moderate AS.

Enrollment: 76 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.Clinical diagnosis of Ankylosing Spondylitis(AS) based on modified New York diagnostic criteria for AS (1984) 2.At the mild-to-moderate stage of AS disease 3.At the active phase of AS disease

Exclusion criteria

• 1.Active tuberculosis, hepatitis, tumors, infection diseases or combine with other rheumaimmune systemic diseases or osteoarthritis diseases 2.Pregnant or breastfeeding women

Trial design

76 participants in 1 patient group

Experimental

Experimental group

Description:

Yisaipu® was introduced only during the active state and was switched to DMARDs, methotrexate(MTX), sulfasalazine(SSZ) and hydroxychloroquine(HCQ), after disease remission (ESR \& CRP reduce to normal and BASDAI\<4) maintenance.

Treatment:

Drug: Yisaipu®