NCT00265083

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis \[AS(arthritis of the spine)\]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
356

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_3

Geographic Reach
9 countries

39 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

December 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 13, 2009

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2013

Enrollment Period

1.2 years

First QC Date

December 12, 2005

Results QC Date

May 21, 2009

Last Update Submit

July 12, 2013

Conditions

Spondylitis, Ankylosing

Keywords

Spondylitissubcutaneous injectionBechterew's DiseaseSpondyloarthritisSpondyloarthropathy

Outcome Measures

Primary Outcomes (1)

  • Assessment in Ankylosing Spondylitis 20 Responders at Week 14

    Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 14 in at least 3 of the 4 domains: patient global, total back pain, function or inflammation.

    Week 14

Secondary Outcomes (3)

  • Assessment in Ankylosing Spondylitis 20 Responders at Week 24

    Week 24

  • Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14

    From Baseline to Week 14

  • Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14

    From Baseline to Week 14

Study Arms (3)

003

EXPERIMENTAL

golimumab 100 mg sc injections every 4 wks from wk 0 up to 5 yrs

Biological: golimumab

001

PLACEBO COMPARATOR

Golimumab (CNTO 148); placebo SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg

Biological: Golimumab (CNTO 148); placebo

002

EXPERIMENTAL

golimumab 50 mg sc injs every 4wks from wk 0 thru 5yrs (unless early escape at wk 16); golimumab - If early escape, 100mg sc injections every 4 wks beginning wk 16 up to 5 yrs ; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg

Biological: golimumab

Interventions

golimumabBIOLOGICAL

100 mg sc injections every 4 wks from wk 0 up to 5 yrs

003
Golimumab (CNTO 148); placeboBIOLOGICAL

SC injections every 4 wks thru wk 20 (unless early escape at wk 16);golimumab - if early escape, 50mg sc inj every 4wks from wk 16 up to 5yrs ;golimumab -50mg sc injection beginning wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100mg

001

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New York criteria, for at least 3 months prior to first dose of study drug
  • Symptoms of active disease at screening and at baseline visits, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of \>= 4, and a Total Back Pain score of \>= 4 (each on a scale of 0 to 10cm)
  • Inadequate response to 3 months of continuous therapy with maximal recommended doses of NSAIDs, or else unable to receive a full 3 months of maximal NSAID therapy because of intolerance, toxicity, or contraindications to non-steroidal anti-inflammatory drugs (NSAIDs)
  • Stable doses of methotrexate, sulfasalazine, hydroxychloroquine, low-dose corticosteroids, and NSAIDs are permitted.

You may not qualify if:

  • Patients cannot have complete ankylosis of the spine
  • No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Unknown Facility

Paradise Valley, Arizona, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Ormond Beach, Florida, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Duncansville, Pennsylvania, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Edmonds, Washington, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Brookfield, Wisconsin, United States

Location

Unknown Facility

La Crosse, Wisconsin, United States

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Diepenbeek, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Sainte-Foy, Quebec, Canada

Location

Unknown Facility

Helsinki, Finland

Location

Unknown Facility

Rauma, Finland

Location

Unknown Facility

Nantes Cedex 01 N/A, France

Location

Unknown Facility

Bad Nauheim, Germany

Location

Unknown Facility

Baden-Baden, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Erlangen, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Herne, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Maastricht, Netherlands

Location

Unknown Facility

Nijmegen, Netherlands

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Pusan, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Taoyuan District, Taiwan

Location

Related Publications (9)

  • Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309.

    PMID: 30412238DERIVED

  • Inman RD, Baraliakos X, Hermann KA, Braun J, Deodhar A, van der Heijde D, Xu S, Hsu B. Serum biomarkers and changes in clinical/MRI evidence of golimumab-treated patients with ankylosing spondylitis: results of the randomized, placebo-controlled GO-RAISE study. Arthritis Res Ther. 2016 Dec 28;18(1):304. doi: 10.1186/s13075-016-1200-1.

    PMID: 28031053DERIVED

  • Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec;43(12):2120-2130. doi: 10.3899/jrheum.160420. Epub 2016 Nov 1.

    PMID: 27803138DERIVED

  • Braun J, Baraliakos X, Hermann KG, Xu S, Hsu B. Serum C-reactive Protein Levels Demonstrate Predictive Value for Radiographic and Magnetic Resonance Imaging Outcomes in Patients with Active Ankylosing Spondylitis Treated with Golimumab. J Rheumatol. 2016 Sep;43(9):1704-12. doi: 10.3899/jrheum.160003. Epub 2016 Jul 15.

    PMID: 27422890DERIVED

  • Braun J, Baraliakos X, Hermann KG, Xu S, Hsu B. Serum Vascular Endothelial Growth Factor Levels Lack Predictive Value in Patients with Active Ankylosing Spondylitis Treated with Golimumab. J Rheumatol. 2016 May;43(5):901-6. doi: 10.3899/jrheum.150897. Epub 2016 Mar 1.

    PMID: 26932345DERIVED

  • Deodhar A, Braun J, Inman RD, van der Heijde D, Zhou Y, Xu S, Han C, Hsu B. Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 5-year results of the GO-RAISE study. Ann Rheum Dis. 2015 Apr;74(4):757-61. doi: 10.1136/annrheumdis-2014-205862. Epub 2014 Nov 11.

    PMID: 25387477DERIVED

  • van der Heijde D, Braun J, Deodhar A, Inman RD, Xu S, Mack ME, Hsu B. Comparison of three enthesitis indices in a multicentre, randomized, placebo-controlled trial of golimumab in ankylosing spondylitis (GO-RAISE). Rheumatology (Oxford). 2013 Feb;52(2):321-5. doi: 10.1093/rheumatology/kes251. Epub 2012 Sep 28.

    PMID: 23024015DERIVED

  • van der Heijde D, Deodhar A, Inman RD, Braun J, Hsu B, Mack M. Comparison of three methods for calculating the Bath Ankylosing Spondylitis Metrology Index in a randomized placebo-controlled study. Arthritis Care Res (Hoboken). 2012 Dec;64(12):1919-22. doi: 10.1002/acr.21771.

    PMID: 22740380DERIVED

  • Deodhar A, Braun J, Inman RD, Mack M, Parasuraman S, Buchanan J, Hsu B, Gathany T, van der Heijde D. Golimumab reduces sleep disturbance in patients with active ankylosing spondylitis: results from a randomized, placebo-controlled trial. Arthritis Care Res (Hoboken). 2010 Sep;62(9):1266-71. doi: 10.1002/acr.20233.

    PMID: 20506403DERIVED

MeSH Terms

Conditions

Spondylitis, AnkylosingSpondylitisSpondylarthritisSpondylarthropathies

Interventions

golimumab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisBone Diseases, InfectiousInfections

Limitations and Caveats

The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.

Results Point of Contact

Title
Director, Clinical Research
Organization
Centocor Research and Development, Inc.
1-800-457-6399

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
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

December 12, 2005

First Posted

December 14, 2005

Study Start

December 1, 2005

Primary Completion

March 1, 2007

Study Completion

January 1, 2012

Last Updated

July 19, 2013

Results First Posted

July 13, 2009

Record last verified: 2013-07

Locations

DE(7)US(11)NL(2)FR(1)CA(7)BE(3)KR(3)TW(3)FI(2)