Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

NCT ID: NCT04333147

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2916 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-12
• Study Completion Date: 2023-02-24

Brief Summary

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

Conditions

Arthritis, Rheumatoid

Study Design

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

Study Groups

Otilimab 90 mg

Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.

Group Type: EXPERIMENTAL

Otilimab (GSK3196165)

Intervention Type: BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

csDMARD(s)

Intervention Type: DRUG

Stable dose of csDMARD(s) as standard of care (SoC).

Otilimab 150 mg

Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.

Group Type: EXPERIMENTAL

Otilimab (GSK3196165)

Intervention Type: BIOLOGICAL

GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

csDMARD(s)

Intervention Type: DRUG

Stable dose of csDMARD(s) as standard of care (SoC).

Interventions

Otilimab (GSK3196165)

GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

Intervention Type: BIOLOGICAL

csDMARD(s)

Stable dose of csDMARD(s) as standard of care (SoC).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants with rheumatoid arthritis who are aged >=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165.
• Body weight >=40 kilograms (kg).
• Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria and agree to abide by the contraceptive requirements.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• For participants on methotrexate (MTX): must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).

Exclusion Criteria

• Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
• Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that

• Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to re- commencing study treatment and agree to complete the remainder of anti-TB treatment while in the study or
• Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specializing in TB on entry to a qualifying study.
• Current or previous active TB regardless of treatment.
• Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation.
• A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator.
• Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease.
• Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation.
• Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study.
• Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study.
• Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant.
• Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
• History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

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

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Flagstaff, Arizona, United States

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Gilbert, Arizona, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Covina, California, United States

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Poway, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Upland, California, United States

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Van Nuys, California, United States

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Whittier, 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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Brandon, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Miami Lakes, Florida, United States

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New Port Richey, Florida, United States

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Orlando, Florida, United States

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Palmetto Bay, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Idaho Falls, Idaho, United States

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Skokie, Illinois, 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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Wheaton, Maryland, 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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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Lebanon, New Hampshire, United States

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Freehold, New Jersey, United States

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Brooklyn, New York, United States

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Fayetteville, North Carolina, United States

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Greensboro, North Carolina, United States

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Minot, North Dakota, United States

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Cincinnati, Ohio, United States

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Vandalia, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Yukon, Oklahoma, United States

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Greenville, South Carolina, United States

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Summerville, South Carolina, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Baytown, Texas, United States

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Colleyville, 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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Houston, Texas, United States

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Lubbock, Texas, United States

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The Woodlands, Texas, United States

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Tomball, Texas, United States

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Waco, 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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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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La Palta, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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San Isidro, Buenos Aires, Argentina

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San Nicolás de los Arroyos, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Rosario, Santa Fe 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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Buenos Aires, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Córdoba, , Argentina

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Nueva Cordoba, , Argentina

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Salta, , Argentina

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San Juan, , Argentina

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Gold Coast, Queensland, Australia

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Woodville, South Australia, Australia

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Mons, , Belgium

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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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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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Vidin, , Bulgaria

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Brampton, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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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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Taizhou, Jiangsu, China

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Xuzhou, Jiangsu, China

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Nanchang, Jiangxi, China

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Pingxiang, Jiangxi, China

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Changchun, Jilin, China

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Jinzhou, Liaoning, China

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Chengdu, Sichuan, China

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Huzhou, Zhejiang, China

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Beijing, , China

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Beijing, , 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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Yangzhou, , China

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Yanji, , China

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Barranquilla, , Colombia

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Bucaramanga, , Colombia

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Brno, , Czechia

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Brno, , Czechia

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Ostrava, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Praha 4 Nusle, , Czechia

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Uherské Hradiště, , Czechia

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Zlín, , Czechia

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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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Dresden, Saxony, Germany

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Rendsburg, Schleswig-Holstein, Germany

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Hamburg, , Germany

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Magdeburg, , Germany

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Baja, , Hungary

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Balatonfüred, , Hungary

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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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Veszprém, , Hungary

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Ahmedabad, , India

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Ahmedabad, , India

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Belagavi, , India

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Hubli, , India

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Hyderabad, , India

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Jaipur, , India

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Jaipur, , India

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Kolkata, , India

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Nagpur, , India

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Nagpur, , India

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New Delhi, , India

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Pune, , India

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Surat, , India

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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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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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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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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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Saitama, , 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

GSK Investigational Site

Wakayama, , Japan

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Yamaguchi, , Japan

GSK Investigational Site

Ādaži, , Latvia

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Liepāja, , Latvia

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Šiauliai, , Lithuania

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Vilnius, , Lithuania

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Klang, , Malaysia

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Kuala Lumpur, , Malaysia

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Seremban, Negeri Sembilan, , Malaysia

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Sibu, , Malaysia

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Mexicali, Baja California Sur, Mexico

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Mexico City, Durango, Mexico

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León, Guanajuato, Mexico

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Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Mérida, Yucatán, Mexico

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Durango, , Mexico

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México, , Mexico

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San Luis Potosí City, , Mexico

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Bialystok, , Poland

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Bialystok, , Poland

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Bydgoszcz, , 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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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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Krakow, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Nowa Sól, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Poznan, , 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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Staszów, , Poland

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Torun, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , 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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Zamość, , 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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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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Saint Petersburg, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Tomsk, , Russia

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Tver', , 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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Yekaterinburg, , Russia

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Belgrade, , Serbia

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Bellville, , South Africa

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Johannesburg, , South Africa

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Johannesburg, , South Africa

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Kempton Park, , South Africa

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Pretoria, , South Africa

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Somerset West, , South Africa

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Stellenbosch, , South Africa

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Anyang-si, , South Korea

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Cheonan-si, , South Korea

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Daegu, , South Korea

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Gwangju, , South Korea

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Incheon, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon-si, Gyeonggi-do, , South Korea

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A Coruña, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Córdoba, , Spain

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Elche, , Spain

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Santander, , Spain

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Santiago de Compostela. La Coruña., , Spain

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Seville, , Spain

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Valencia, , Spain

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Bangkok, , Thailand

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Rajathevee, , Thailand

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Cherkasy, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Lutsk, , Ukraine

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Lutsk, , Ukraine

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Odesa, , Ukraine

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Poltava, , Ukraine

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Vinnytsia, , Ukraine

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Vinnytsia, , Ukraine

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Vinnytsia, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhia, , Ukraine

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Zaporizhzia, , Ukraine

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Zhytomyr, , Ukraine

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Orpington, Kent, United Kingdom

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Northwood, Middlesex, United Kingdom

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Coventry, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Bulgaria; Canada; China; Colombia; Czechia; Estonia; Germany; Hungary; India; Japan; Latvia; Lithuania; Malaysia; Mexico; Poland; Russia; Serbia; South Africa; South Korea; Spain; Thailand; Ukraine; United Kingdom

References

Weinblatt ME, Taylor PC, McInnes IB, Atsumi T, Strand V, Takeuchi T, Bracher M, Brooks D, Curtis P, Gupta A, Nijhawan R, O'Shea C, Rayner K, Saurigny D, Shelton C, Wang M, Wang R, Fleischmann RM. Long-term safety and efficacy of anti-GM-CSF otilimab in patients with rheumatoid arthritis: long-term extension of three phase 3 randomised trials (contRAst X). BMJ Open. 2025 Mar 5;15(3):e088869. doi: 10.1136/bmjopen-2024-088869.

Reference Type: DERIVED

PMID: 40044198 (View on PubMed)

Provided Documents

Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Related Links

https://clinicaltrials.gov/ct2/show/NCT03980483?term=201790&draw=2&rank=2

201790 contRAst 1 NCT03980483

https://clinicaltrials.gov/ct2/show/NCT03970837?term=201791&draw=2&rank=2

201791 contRAst 2 NCT03970837

https://clinicaltrials.gov/ct2/show/NCT04134728?term=202018&draw=2&rank=1

202018 contRAst 3 NCT04134728

Other Identifiers

209564

Identifier Type: -

Identifier Source: org_study_id