A Study of Golimumab in Participants With Active Ankylosing Spondylitis

NCT ID: NCT02186873

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-03
• Study Completion Date: 2016-10-11

Brief 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 the axial skeleton, entheses, and peripheral joints).

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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group 1: Placebo then Golimumab

Participants 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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive matching placebo.

Golimumab

Intervention Type: DRUG

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

Treatment Group 2: Golimumab

Participants 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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive matching placebo.

Golimumab

Intervention Type: DRUG

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

Interventions

Placebo

Participants will receive matching placebo.

Intervention Type: DRUG

Golimumab

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

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Glendale, Arizona, United States

Mesa, Arizona, United States

La Palma, California, United States

Granger, Indiana, United States

St Louis, Missouri, United States

Orchard Park, New York, United States

Salisbury, North Carolina, United States

Middleburg Heights, Ohio, United States

Duncansville, Pennsylvania, United States

Austin, Texas, United States

Houston, Texas, United States

Maroochydore, , Australia

St. John's, Newfoundland and Labrador, Canada

Burlington, , Canada

Trois-Rivières, , Canada

Bad Doberan, , Germany

Berlin, , Germany

Erfurt, , Germany

Hamburg, , Germany

Planegg, , Germany

Ratingen, , Germany

Zerbst, , Germany

Chihuahua City, , Mexico

Bydgoszcz, , Poland

Bytom, , Poland

Nadarzyn, , Poland

Nowa Sól, , Poland

Poznan, , Poland

Warsaw, , Poland

Moscow, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Smolensk, , Russia

Tver', , Russia

Ansan, , South Korea

Daegu, , South Korea

Gwangju, , South Korea

Seongdong-Gu, , South Korea

Seoul, , South Korea

Chernihiv, , Ukraine

Dnipropetrovsk, , Ukraine

Kyiv, , Ukraine

Odesa, , Ukraine

Vinnytsia, , Ukraine

Zaporizhzhia, , Ukraine

Countries

United States; Australia; Canada; Germany; Mexico; Poland; Russia; South Korea; Ukraine

References

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.

Reference Type: DERIVED

PMID: 37322274 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35653615 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35313978 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32926247 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29247154 (View on PubMed)

Other Identifiers

CNTO148AKS3001

Identifier Type: OTHER

Identifier Source: secondary_id

2014-000241-74

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR103795

Identifier Type: -

Identifier Source: org_study_id