Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01248793
First received: November 24, 2010
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Ankylosing Spondylitis
Drug: Placebo
Drug: Golimumab
Drug: Golimumab (placebo group)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation


Secondary Outcome Measures:
  • Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation

  • Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14 [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]
    BASFI is a participant's self-assessment, represented as a mean (Visual Analogue Scale [Score]; 0 cm [easy] to 10 cm [impossible]) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. A negative change from baseline indicates improvement.

  • Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14 [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]
    BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.


Enrollment: 213
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo Drug: Placebo
Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20
Drug: Golimumab (placebo group)
Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48
Experimental: Golimumab Drug: Golimumab
Golimumab 50 mg SC injection every 4 weeks for 48 weeks

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248793

Locations
China
Beijing, China
Chengdu, China
Guangzhou, China
Hefei, China
Jinan, China
Shanghai, China
Xi'An, China
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided by Centocor, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01248793     History of Changes
Other Study ID Numbers: CR015916, C0524T29
Study First Received: November 24, 2010
Results First Received: May 25, 2012
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor, Inc.:
Ankylosing Sponylitis, injection, golimumab, simponi

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies

ClinicalTrials.gov processed this record on October 29, 2014