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Ankylosing SpondylitisPhase 3NCT02186873

A Study of Golimumab in Participants With Active Ankylosing Spondylitis

A Phase 3 study testing Golimumab in people with Ankylosing Spondylitis, run by Janssen Research & Development, LLC at 45 sites in 9 countries.

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 efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, and often… 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
208 participants
Where
45 sitesin 9 countries
Study dates
3 Sep 2014to 11 Oct 2016
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

  • Participants with diagnosis of definite ankylosing spondylitis for at least 3 months based on modified New York radiographic and clinical criteria
  • Participants with symptoms of active disease at screening and at baseline
  • Participant has either an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAID) over a 4 week period in total with maximal recommended doses of NSAIDs, or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs
  • Participants with C- reactive protein (CRP) level of greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) at screening
  • Additional protocol-defined inclusion criteria apply

Who cannot join

  • Participant with other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
  • Pregnant or lactating females
  • Participants with chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis
  • Participants who had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis, or pyelonephritis), 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
  • Additional protocol-defined exclusion criteria apply

Trial locations and contacts

45 sites in 9 countries.

45 sites in 9 countries

United States11 sites

  • Study site

    Austin, Texas

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Glendale, Arizona

  • Study site

    Granger, Indiana

  • Study site

    Houston, Texas

  • Study site

    La Palma, California

  • Study site

    Mesa, Arizona

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Orchard Park, New York

  • Study site

    Salisbury, North Carolina

  • Study site

    St Louis, Missouri

Other trials in United States

Germany7 sites

  • Study site

    Bad Doberan

  • Study site

    Berlin

  • Study site

    Erfurt

  • Study site

    Hamburg

  • Study site

    Planegg

  • Study site

    Ratingen

  • Study site

    Zerbst

Other trials in Germany

Poland6 sites

  • Study site

    Bydgoszcz

  • Study site

    Bytom

  • Study site

    Nadarzyn

  • Study site

    Nowa Sól

  • Study site

    Poznan

  • Study site

    Warsaw

Other trials in Poland

Ukraine6 sites

  • Study site

    Chernihiv

  • Study site

    Dnipropetrovsk

  • Study site

    Kyiv

  • Study site

    Odesa

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Russia5 sites

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Smolensk

  • Study site

    Tver'

Other trials in Russia

South Korea5 sites

  • Study site

    Ansan

  • Study site

    Daegu

  • Study site

    Gwangju

  • Study site

    Seongdong-Gu

  • Study site

    Seoul

Other trials in South Korea

Canada3 sites

  • Study site

    Burlington

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Trois-Rivières

Other trials in Canada

Australia1 site

  • Study site

    Maroochydore

Other trials in Australia

Mexico1 site

  • Study site

    Chihuahua City

Other trials in Mexico

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis

The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral joints).

Read the detailed description

This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of golimumab compared with placebo in participants with active ankylosing spondylitis. The study comprises of 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase (Week 0 to Week 16), Active treatment phase (Week 16 to Week 52), and Safety follow-up phase (8 weeks from last study drug administration). Total duration of the study will be 60 weeks per participant. Eligible Participants will be randomly assigned to either Treatment group 1: Placebo or Treatment group 2: Golimumab. Participants randomized to Placebo group, will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab (2 mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab group, will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants randomized to golimumab group will receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by measuring percentage of participants who achieve a 20 percent improvement from baseline in the assessment in ankylosing spondylitis (ASAS) at Week 16. Participant's safety will be monitored throughout the study.

Being tested
Placebo, Golimumab
Keywords
Ankylosing Spondylitis, 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

    Participants will receive matching placebo.

  • GolimumabDrug

    Participants will receive 2mg/kg of intravenous infusions of golimumab .

Study groups in NCT02186873
Study groupRoleWhat they receive
Treatment Group 1: Placebo then GolimumabExperimentalParticipants will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52.
Receives: Drug: Placebo; Drug: Golimumab
Treatment Group 2: GolimumabExperimentalParticipants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants will receive a placebo infusion to maintain the blind.
Receives: Drug: Placebo; Drug: Golimumab

What is being measured

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

  1. Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16

    ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.

    Measured: Week 16

Secondary outcomes (8)

  1. Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16

    An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain.

    Measured: Week 16

  2. Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16

    The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.

    Measured: Week 16

  3. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16

    The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 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.

    Measured: Baseline and Week 16

  4. Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16

    The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.

    Measured: Baseline and Week 16

  5. Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16

    The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.

    Measured: Baseline and Week 16

  6. Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16

    Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation.

    Measured: Week 16

  7. Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16

    The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL.

    Measured: Baseline and Week 16

  8. Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16

    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.

    Measured: Baseline and Week 16

Timeline

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

  1. First posted10 Jul 2014 (estimated)
  2. Study start3 Sep 2014
  3. Primary completion15 Dec 2015
  4. Study completion11 Oct 2016

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
Double blind
Who is masked
Participant, Investigator
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02186873
Sponsor's protocol ID
CR103795
Other IDs
CNTO148AKS3001, 2014-000241-74, 2014
Status last verified
Oct 2025
First submitted
8 Jul 2014
Last updated
30 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes

Publications

  • Deodhar A, Shiff NJ, Gong C, Chan EKH, Hsia EC, Lo KH, Akawung A, Kim L, Xu S, Reveille JD. Effect of Intravenous Golimumab on Fatigue and the Relationship with Clinical Response in Adults with Active Ankylosing Spondylitis in the Phase 3 GO-ALIVE Study. Rheumatol Ther. 2023 Aug;10(4):983-999. doi: 10.1007/s40744-023-00556-y. Epub 2023 Jun 15.

    PubMed 37322274

  • Deodhar AA, Shiff NJ, Gong C, Hsia EC, Lo KH, Kim L, Xu S, Reveille JD. Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through One Year of the GO-ALIVE Study. J Clin Rheumatol. 2022 Aug 1;28(5):270-277. doi: 10.1097/RHU.0000000000001853. Epub 2022 Jun 1.

    PubMed 35653615

  • Husni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, Zhou Y, Lo KH, Kavanaugh A. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022 Mar 21;24(1):73. doi: 10.1186/s13075-022-02753-6.

    PubMed 35313978

  • Reveille JD, Hwang MC, Danve A, Kafka S, Peterson S, Lo KH, Kim L, Hsia EC, Chan EKH, Deodhar A. The effect of intravenous golimumab on health-related quality of life and work productivity in adult patients with active ankylosing spondylitis: results of the phase 3 GO-ALIVE trial. Clin Rheumatol. 2021 Apr;40(4):1331-1341. doi: 10.1007/s10067-020-05342-7. Epub 2020 Sep 14.

    PubMed 32926247

  • Deodhar A, Reveille JD, Harrison DD, Kim L, Lo KH, Leu JH, Hsia EC. Safety and Efficacy of Golimumab Administered Intravenously in Adults with Ankylosing Spondylitis: Results through Week 28 of the GO-ALIVE Study. J Rheumatol. 2018 Mar;45(3):341-348. doi: 10.3899/jrheum.170487. Epub 2017 Dec 15.

    PubMed 29247154

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Golimumab in people with Ankylosing Spondylitis, run by Janssen Research & Development, LLC at 45 sites in 9 countries.

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 5 inclusion and 5 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 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Germany, Poland, Ukraine, Russia and 4 more countries. 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 13 Nov 2017). 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?

Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16 (time frame: Week 16). 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 NCT02186873, which also lists 5 linked publications.

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 30 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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