Clinical trial NCT01248793: Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Sponylitis, injection, golimumab, simponi
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-25
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, so 50% chance to receive golimumab and 50% change to receive placebo. Patients who do not have an improvement in total back pain and morning stiffness at the Week 16 visit compared to when the patients entered the study, and are in Group 1 (placebo group), will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), they will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and still receiving placebo injections, because there was improvement in total back pain at Week 16, they will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or are already receiving golimumab injections at week 24, they will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks until Week 48.

Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14
timeFrame: Week 14
Secondary outcomes:
measure: Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24
timeFrame: Week 24
measure: Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
timeFrame: Baseline and Week 14
measure: Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14
timeFrame: Baseline and Week 14
Other outcomes:
Locations:
city: Beijing
country: China
city: Chengdu
country: China
city: Guangzhou
country: China
city: Hefei
country: China
city: Jinan
country: China
city: Shanghai
country: China
city: Xi'An
country: China
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.