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Ankylosing SpondylitisPhase 3NCT01248793

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

A Phase 3 study testing Golimumab in people with Ankylosing Spondylitis, run by Centocor, Inc. at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Golimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
213 participants
Where
7 sitesChina
Study dates
Oct 2010to Mar 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Study site

    Beijing

  • Study site

    Chengdu

  • Study site

    Guangzhou

  • Study site

    Hefei

  • Study site

    Jinan

  • Study site

    Shanghai

  • Study site

    Xi'an

Other trials in China

About this study

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

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

Read the 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.

Being tested
Placebo, Golimumab, Golimumab (placebo group)
Keywords
Ankylosing Sponylitis, injection, golimumab, simponi
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • GolimumabDrug

    Golimumab 50 mg SC injection every 4 weeks for 48 weeks

  • 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

Study groups in NCT01248793
Study groupRoleWhat they receive
PlaceboExperimentalNot described
Receives: Drug: Placebo; Drug: Golimumab (placebo group)
GolimumabExperimentalNot described
Receives: Drug: Golimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 14

Secondary outcomes (3)

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

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

    Measured: Week 24

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

    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.

    Measured: Baseline and Week 14

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

    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.

    Measured: Baseline and Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionMay 2011
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01248793
Sponsor's protocol ID
CR015916
Other IDs
C0524T29
Status last verified
Mar 2013
First submitted
24 Nov 2010
Last updated
20 Mar 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 24729398

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Golimumab in people with Ankylosing Spondylitis, run by Centocor, Inc. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 (time frame: Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01248793, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.

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