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New IV drug shows promise for stiff spine disease

NCT ID NCT02186873

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested golimumab, an anti-inflammatory biologic, given as an IV infusion to 208 people with active ankylosing spondylitis. Participants received either golimumab or a placebo. The main goal was to see if more people on golimumab had at least a 20% improvement in symptoms by week 16. The study is complete and aimed at finding a new option for those not helped by standard anti-inflammatory drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
golimumab (a biologic drug given as an intravenous infusion)
What this could lead to
If successful, this could provide a new treatment option for people with active ankylosing spondylitis who haven't responded to standard anti-inflammatory drugs.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. As an immune-suppressing drug, golimumab carries risks like serious infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

208 people

The number who actually took part.

Started

Sep 2014

Finished

Oct 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankylosing spondylitis

Contacts and locations

Locations

  • Study site

    Glendale, Arizona, United States

  • Study site

    Mesa, Arizona, United States

  • Study site

    La Palma, California, United States

  • Study site

    Granger, Indiana, United States

  • Study site

    St Louis, Missouri, United States

  • Study site

    Orchard Park, New York, United States

  • Study site

    Salisbury, North Carolina, United States

  • Study site

    Middleburg Heights, Ohio, United States

  • Study site

    Duncansville, Pennsylvania, United States

  • Study site

    Austin, Texas, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Maroochydore, Australia

  • Study site

    St. John's, Newfoundland and Labrador, Canada

  • Study site

    Burlington, Canada

  • Study site

    Trois-Rivières, Canada

  • Study site

    Bad Doberan, Germany

  • Study site

    Berlin, Germany

  • Study site

    Erfurt, Germany

  • Study site

    Hamburg, Germany

  • Study site

    Planegg, Germany

  • Study site

    Ratingen, Germany

  • Study site

    Zerbst, Germany

  • Study site

    Chihuahua City, Mexico

  • Study site

    Bydgoszcz, Poland

  • Study site

    Bytom, Poland

  • Study site

    Nadarzyn, Poland

  • Study site

    Nowa Sól, Poland

  • Study site

    Poznan, Poland

  • Study site

    Warsaw, Poland

  • Study site

    Moscow, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Saratov, Russia

  • Study site

    Smolensk, Russia

  • Study site

    Tver', Russia

  • Study site

    Ansan, South Korea

  • Study site

    Daegu, South Korea

  • Study site

    Gwangju, South Korea

  • Study site

    Seongdong-Gu, South Korea

  • Study site

    Seoul, South Korea

  • Study site

    Chernihiv, Ukraine

  • Study site

    Dnipropetrovsk, Ukraine

  • Study site

    Kyiv, Ukraine

  • Study site

    Odesa, Ukraine

  • Study site

    Vinnytsia, Ukraine

  • Study site

    Zaporizhzhia, Ukraine

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