NCT01248793

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

7 active sites

Status
completed

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, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 28, 2012

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

November 24, 2010

Results QC Date

May 25, 2012

Last Update Submit

March 14, 2013

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Sponylitis, injection, golimumab, simponi

Outcome Measures

Primary Outcomes (1)

  • Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14

    Number of patients who achieved a \>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation

    Week 14

Secondary Outcomes (3)

  • Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24

    Week 24

  • Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14

    Baseline and Week 14

  • Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14

    Baseline and Week 14

Study Arms (2)

Placebo

EXPERIMENTAL
Drug: PlaceboDrug: Golimumab (placebo group)

Golimumab

EXPERIMENTAL
Drug: Golimumab

Interventions

PlaceboDRUG

Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20

Placebo
GolimumabDRUG

Golimumab 50 mg SC injection every 4 weeks for 48 weeks

Golimumab
Golimumab (placebo group)DRUG

Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48

Placebo

Eligibility Criteria

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

You may qualify if:

  • \- Have a diagnosis of definite akylosing spondylitis for at least 3 months
  • Have symptoms of active disease at screening and at baseline
  • no active infections

You may not qualify if:

  • Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
  • Have complete ankylosis of the spine
  • Have a history of latent or active granulomatous infection
  • Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hefei, China

Location

Unknown Facility

Jinan, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Xi'an, China

Location

Related Publications (1)

  • Bao C, Huang F, Khan MA, Fei K, Wu Z, Han C, Hsia EC. Safety and efficacy of golimumab in Chinese patients with active ankylosing spondylitis: 1-year results of a multicentre, randomized, double-blind, placebo-controlled phase III trial. Rheumatology (Oxford). 2014 Sep;53(9):1654-63. doi: 10.1093/rheumatology/keu132. Epub 2014 Apr 11.

    PMID: 24729398DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

golimumab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Results Point of Contact

Title
Associate Director, Clinical Research
Organization
Janssen Research & Development
610-500-3369

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 25, 2010

Study Start

October 1, 2010

Primary Completion

May 1, 2011

Study Completion

March 1, 2012

Last Updated

March 20, 2013

Results First Posted

June 28, 2012

Record last verified: 2013-03

Locations

CN(7)