NCT00889694

Brief Summary

This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to investigate whether tripterygium capsule is effective and safe in treating patients with ankylosing spondylitis. The investigators expect that the tripterygium capsule is more effective than placebo and has few adverse effects.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

9 months

First QC Date

April 27, 2009

Last Update Submit

April 27, 2009

Conditions

Early Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • ASAS20

    12th week

Secondary Outcomes (1)

  • BASDAI20/50/70

    12th week

Interventions

TripterygiumDRUG

Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.

SulfasalazineDRUG

Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.

placeboDRUG

Placebo: 2 capsules per time, 3 times per day for 12 weeks.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and inflammatory bowel disease associated arthritis.
  • Disease is in active status defined by BASDAI\>=40mm.
  • DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs dose must be stable for at least 4 weeks before screening.

You may not qualify if:

  • Intra-articular injection of glucocorticoid within 3 months.
  • Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors.
  • Accompanied by fibromyalgia syndrome or other rheumatic diseases.
  • Female of pregnancy or breast-feeding.
  • Poor compliance or with mental diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Sulfasalazine

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 29, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

April 29, 2009

Record last verified: 2009-04