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

NCT03411798 | Completed Phase 4

• 1 other identifier: NFEC-201711-K6
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis(AS); TNFi; Yisaipu®; Disease modifying anti-rheumatic drugs (DMARDs)

Outcome Measures

Primary Outcomes (6)

• ASAS 20

  Improvement of \>20% and \>1 unit in at least 3 domains on a scale of 10;No worsening of \>20% and \>1 unit in remaining domain on a scale of 10 compare to the baseline status

  3 months after

• ASAS 20

  Improvement of \>20% and \>1 unit in at least 3 domains on a scale of 10;No worsening of \>20% and \>1 unit in remaining domain on a scale of 10 compare to the baseline status

  6 months after

• ASAS 20

  Improvement of \>20% and \>1 unit in at least 3 domains on a scale of 10;No worsening of \>20% and \>1 unit in remaining domain on a scale of 10 compare to the baseline status

  12 months after

• ASAS 40

  Improvement of \>40% and \>2 unit in at least 3 domains on a scale of 10;No worsening at all in remaining domain compare to the baseline status

  3 months after

• ASAS 40

  Improvement of \>40% and \>2 unit in at least 3 domains on a scale of 10;No worsening at all in remaining domain compare to the baseline status

  6 months after

• ASAS 40

  Improvement of \>40% and \>2 unit in at least 3 domains on a scale of 10;No worsening at all in remaining domain compare to the baseline status

  12 months after

Secondary Outcomes (6)

• BASDAI

  baseline,3 months after,6 months after,12 months after

• BASFI

  baseline,3 months after,6 months after,12 months after

• Patient Global Assessment

  baseline,3 months after,6 months after,12 months after

• CRP

  baseline,3 months after,6 months after,12 months after

• ESR

  baseline,3 months after,6 months after,12 months after

Study Arms (1)

Experimental

EXPERIMENTAL

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.

Drug: Yisaipu®

Interventions

Yisaipu® DRUG

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.

Also known as: methotrexate(MTX), sulfasalazine(SSZ), hydroxychloroquine(HCQ)

Experimental

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Methotrexate; Sulfasalazine; Hydroxychloroquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Chloroquine; Aminoquinolines; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 26, 2018
• Study Start: December 15, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-07

Locations

CN (1)