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Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)

NCT ID: NCT03970837

Last Updated: 2023-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1764 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2023-01-18

Brief Summary

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This study \[contRAst 2 (201791: NCT03970837)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study \[contRAst X (209564: NCT04333147)\]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

Detailed Description

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Conditions

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Arthritis, Rheumatoid

Keywords

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Rheumatoid Arthritis GSK3196165 Otilimab Tofacitinib Placebo DMARDs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to one of six intervention arms in ratio of 6:6:3:1:1:1
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double blinded

Study Groups

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GSK3196165 90mg + csDMARD (Global Cohort)

Participants in Global Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARD).

Group Type EXPERIMENTAL

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

GSK3196165 150mg + csDMARD (Global Cohort)

Participants in Global Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.

Group Type EXPERIMENTAL

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

Tofacitinib 5mg + csDMARD (Global Cohort)

Participants in Global Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.

Group Type ACTIVE_COMPARATOR

Tofacitinib

Intervention Type DRUG

Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.

Placebo + csDMARD and GSK3196165 90mg + csDMARD (Global Cohort)

Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

Group Type PLACEBO_COMPARATOR

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

Placebo

Intervention Type DRUG

Placebo matching GSK3196165 and Tofacitinib was administered.

Placebo +csDMARD and GSK3196165 150mg +csDMARD (Global Cohort)

Participants in Global Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

Group Type PLACEBO_COMPARATOR

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

Placebo

Intervention Type DRUG

Placebo matching GSK3196165 and Tofacitinib was administered.

Placebo +csDMARD and Tofacitinib 5mg +csDMARD (Global Cohort)

Participants in Global Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.

Group Type PLACEBO_COMPARATOR

Tofacitinib

Intervention Type DRUG

Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.

Placebo

Intervention Type DRUG

Placebo matching GSK3196165 and Tofacitinib was administered.

GSK3196165 90mg + csDMARD (Asia Cohort)

Participants in Asia Cohort received GSK3196165 90 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.

Group Type EXPERIMENTAL

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

GSK3196165 150mg + csDMARD (Asia Cohort)

Participants in Asia Cohort received GSK3196165 150 mg subcutaneous (SC) injection once weekly for 52 weeks in combination with csDMARD.

Group Type EXPERIMENTAL

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

Tofacitinib 5mg + csDMARD (Asia Cohort)

Participants in Asia Cohort received Tofacitinib 5mg capsule, orally, twice daily (BID) in combination with csDMARD plus placebo injection weekly to maintain the blind for 52 weeks.

Group Type ACTIVE_COMPARATOR

Tofacitinib

Intervention Type DRUG

Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.

Placebo + csDMARD and GSK3196165 90mg + csDMARD (Asia Cohort)

Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 90 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

Group Type PLACEBO_COMPARATOR

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

Placebo

Intervention Type DRUG

Placebo matching GSK3196165 and Tofacitinib was administered.

Placebo + csDMARD and GSK3196165 150mg + csDMARD (Asia Cohort)

Participants in Asia Cohort received Placebo weekly SC injection in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo to GSK3196165 150 mg, SC injection, once weekly in combination with csDMARD until 52 weeks.

Group Type PLACEBO_COMPARATOR

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

Placebo

Intervention Type DRUG

Placebo matching GSK3196165 and Tofacitinib was administered.

Placebo + csDMARD and Tofacitinib 5mg + csDMARD (Asia Cohort)

Participants in Asia Cohort received Placebo capsule BID in combination with csDMARD for 12 weeks. At week 12, participants were switched from placebo capsule to Tofacitinib 5mg, capsule, orally, BID in combination with csDMARD plus placebo injection to maintain the blind for 52 weeks.

Group Type PLACEBO_COMPARATOR

Tofacitinib

Intervention Type DRUG

Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.

Placebo

Intervention Type DRUG

Placebo matching GSK3196165 and Tofacitinib was administered.

Interventions

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GSK3196165 (Otilimab)

GSK3196165 solution in vial/pre-filled syringe (PFS) was administered SC.

Intervention Type BIOLOGICAL

Tofacitinib

Tofacitinib capsule (over encapsulated 5mg tablet) was administered orally.

Intervention Type DRUG

Placebo

Placebo matching GSK3196165 and Tofacitinib was administered.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \>=18 years of age
* Has had RA for \>=6 months and was not diagnosed before 16 years of age
* Has active disease, as defined by having both\*

* \>=6/68 tender/painful joint count (TJC), and
* \>=6/66 swollen joint count (SJC)
* Has at least 1 bone erosion present on hand/wrist or foot radiographs
* Has had an inadequate response to one or two of the csDMARDs:

* methotrexate (MTX) 15-25 mg/week\*\* oral or injected
* hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day
* sulfasalazine up to 3000 mg/day
* leflunomide up to 20 mg/day\*\*\*
* bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement)
* iguratimod up to 50 mg/day

* If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.

* A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.

* Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons.

Exclusion Criteria

* History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren's syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
* Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
* Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iqvia Pty Ltd

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Flagstaff, Arizona, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Tucson, Arizona, United States

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Poway, California, United States

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Riverside, California, United States

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Roseville, California, United States

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San Diego, California, United States

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Tustin, California, United States

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Van Nuys, California, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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Aventura, Florida, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Gainesville, Florida, United States

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Hialeah, Florida, United States

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Margate, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Palmetto Bay, Florida, United States

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St. Petersburg, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Marietta, Georgia, United States

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Idaho Falls, Idaho, United States

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Evansville, Indiana, United States

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Wichita, Kansas, United States

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Bowling Green, Kentucky, United States

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Lake Charles, Louisiana, United States

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Monroe, Louisiana, United States

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Hagerstown, Maryland, United States

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Worcester, Massachusetts, United States

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Grand Blanc, Michigan, United States

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Lansing, Michigan, United States

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Novi, Michigan, United States

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Freehold, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Greensboro, North Carolina, United States

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Minot, North Dakota, United States

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Oklahoma City, Oklahoma, United States

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Yukon, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Columbia, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Summerville, South Carolina, United States

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Knoxville, Tennessee, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Colleyville, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Tomball, Texas, United States

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Glendale, Wisconsin, United States

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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Buenos Aires, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Córdoba, , Argentina

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San Juan, , Argentina

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Westmead, New South Wales, Australia

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Gold Coast, Queensland, Australia

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Woodville, South Australia, Australia

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Hobart, Tasmania, Australia

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Box Hill, Victoria, Australia

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Heidelberg West, Victoria, Australia

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Blagoevgrad, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Rousse, , Bulgaria

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Sevlievo, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Vidin, , Bulgaria

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Bengbu, Anhui, China

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Guilin, Guangxi, China

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Shijiazhuang, Hebei, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Zhuzhou, Hunan, China

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Baotou, Inner Mongolia, China

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Tongliao, Inner Mongolia, China

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Nanjing, Jiangsu, China

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Taizhou, Jiangsu, China

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Xuzhou, Jiangsu, China

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Yancheng, Jiangsu, China

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Jiujiang, Jiangxi, China

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Nanchang, Jiangxi, China

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Changchun, Jilin, China

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Jinzhou, Liaoning, China

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Huzhou, Zhejiang, China

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Beijing, , China

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Beijing, , China

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Changchun, , China

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Changzhou, , China

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Chengdu, , China

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Guangzhou, , China

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Guangzhou, , China

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Hangzhou, , China

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Nanjing, , China

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Shanghai, , China

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Tianjin, , China

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Xi'an, , China

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Yangzhou, , China

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Yanji, , China

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Bucaramanga, , Colombia

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Medellín, , Colombia

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Pärnu, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Tartu, , Estonia

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Cahors, , France

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Dresden, Saxony, Germany

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Rendsburg, Schleswig-Holstein, Germany

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Berlin, , Germany

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Hamburg, , Germany

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Magdeburg, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Szentes, , Hungary

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Székesfehérvár, , Hungary

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Aichi, , Japan

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Aichi, , Japan

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Aichi, , Japan

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Chiba, , Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Hiroshima, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Hyōgo, , Japan

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Ibaraki, , Japan

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Kagawa, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kochi, , Japan

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Kochi, , Japan

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Kumamoto, , Japan

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Miyagi, , Japan

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Miyagi, , Japan

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Nagano, , Japan

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Nagasaki, , Japan

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Nagasaki, , Japan

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Nagasaki, , Japan

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Niigata, , Japan

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Niigata, , Japan

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Okayama, , Japan

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Okayama, , Japan

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Okayama, , Japan

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Saga, , Japan

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Saitama, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tottori, , Japan

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Wakayama, , Japan

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Yamaguchi, , Japan

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Mexico City, Durango, Mexico

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Guadalajara, Jalisco, Mexico

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Mérida, Yucatán, Mexico

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San Luis Potosí City, , Mexico

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Częstochowa, , Poland

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Elblag, , Poland

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Gdansk, , Poland

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Gdynia, , Poland

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Grodzisk Mazowiecki, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Nowy Targ, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Siedlce, , Poland

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Sochaczew, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Kemerovo, , Russia

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Kemerovo, , Russia

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Korolyov, , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Omsk, , Russia

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Saint Petersburg, , Russia

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Tomsk, , Russia

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Ulyanovsk, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Anyang-Si, Gyeonggi-do, , South Korea

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Cheonan-si, , South Korea

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Daegu, , South Korea

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Daegu, , South Korea

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Gwangju, , South Korea

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GSK Investigational Site

Incheon, , South Korea

Site Status

GSK Investigational Site

Seongnam-si, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Suwon, , South Korea

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Santander, , Spain

Site Status

GSK Investigational Site

Seville, , Spain

Site Status

GSK Investigational Site

Bangkok, , Thailand

Site Status

GSK Investigational Site

Muang, , Thailand

Site Status

GSK Investigational Site

Rajathevee, , Thailand

Site Status

GSK Investigational Site

Romford, Essex, United Kingdom

Site Status

GSK Investigational Site

Northwood, Middlesex, United Kingdom

Site Status

GSK Investigational Site

Kenilworth, Warwickshire, United Kingdom

Site Status

Countries

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Brazil United States Argentina Australia Bulgaria China Colombia Estonia France Germany Hungary Japan Mexico Poland Russia South Korea Spain Thailand United Kingdom

References

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Fleischmann RM, van der Heijde D, Strand V, Atsumi T, McInnes IB, Takeuchi T, Taylor PC, Bracher M, Brooks D, Davies J, Goode C, Gupta A, Mukherjee S, O'Shea C, Saurigny D, Schifano LA, Shelton C, Smith JE, Wang M, Wang R, Watts S, Weinblatt ME. Anti-GM-CSF otilimab versus tofacitinib or placebo in patients with active rheumatoid arthritis and an inadequate response to conventional or biologic DMARDs: two phase 3 randomised trials (contRAst 1 and contRAst 2). Ann Rheum Dis. 2023 Dec;82(12):1516-1526. doi: 10.1136/ard-2023-224482. Epub 2023 Sep 12.

Reference Type DERIVED
PMID: 37699654 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://clinicaltrials.gov/ct2/show/NCT04333147?term=209564&draw=2&rank=1

209564 contRAst X NCT04333147

Other Identifiers

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201791

Identifier Type: -

Identifier Source: org_study_id