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Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors

NCT ID: NCT04134728

Last Updated: 2023-07-17

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2022-02-01

Brief Summary

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This study (contRAst 3 \[202018: NCT04134728\]) is a Phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of GSK3196165 in combination with conventional (cs) DMARD\[s\]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to biologic (b) DMARD\[s\]) and/or JAK inhibitors. The study will consist of a screening phase of up to 6 weeks followed by 24 week treatment phase in which participants will be randomized in ratio of 6:6:6:1:1:1 to GSK3196165 150 milligrams (mg) subcutaneously (SC) weekly,GSK3196165 90 mg SC weekly, sarilumab 200 mg SC every other week or placebo (three arms) respectively, all in combination with background csDMARD(s). At Week 12, participants in the three placebo arms will switch from placebo to active intervention (either GSK3196165 150 mg SC weekly, GSK3196165 90 mg SC weekly, or sarilumab 200 mg SC every other week). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study (contRAst X \[209564: NCT04333147\]). Any participant who does not transition into study 209564 will undergo a safety follow-up visit at Week 34 (corresponding to 12 weeks after the last potential dose of sarilumab, at Week 22).

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Detailed Description

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Conditions

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Arthritis, Rheumatoid

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 6:6:6:1:1:1
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blinded

Study Groups

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GSK3196165 90 mg

Entire treatment period (24 Weeks): GSK3196165 90 mg SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as standard of care (SoC).

Group Type EXPERIMENTAL

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

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

csDMARDs

Intervention Type DRUG

Stable dose of csDMARD(s) as SoC.

GSK3196165 150 mg

Entire treatment period (24 Weeks): GSK3196165 150 mg SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as SoC.

Group Type EXPERIMENTAL

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

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

csDMARDs

Intervention Type DRUG

Stable dose of csDMARD(s) as SoC.

Sarilumab 200 mg

Entire treatment period (24 Weeks): Sarilumab 200 mg SC injection every other week + placebo SC injection in the intervening weeks. Participants will also receive a stable dose of csDMARD(s) as SoC.

Group Type ACTIVE_COMPARATOR

Sarilumab

Intervention Type BIOLOGICAL

Sarilumab solution in PFS to be administered SC.

Placebo to GSK3196165/ Sarilumab

Intervention Type DRUG

Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/PFS to be administered SC.

csDMARDs

Intervention Type DRUG

Stable dose of csDMARD(s) as SoC.

Placebo sequence 1

From Week 0-11: Placebo SC injection once weekly. From Week 12 onwards: GSK3196165 90 mg SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as SoC.

Group Type PLACEBO_COMPARATOR

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

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

Placebo to GSK3196165/ Sarilumab

Intervention Type DRUG

Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/PFS to be administered SC.

csDMARDs

Intervention Type DRUG

Stable dose of csDMARD(s) as SoC.

Placebo sequence 2

From Week 0-11: Placebo SC injection once weekly. From Week 12 onwards: GSK3196165 150 mg SC injection once weekly. Participants will also receive a stable dose of csDMARD(s) as SoC.

Group Type PLACEBO_COMPARATOR

GSK3196165 (Otilimab)

Intervention Type BIOLOGICAL

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

Placebo to GSK3196165/ Sarilumab

Intervention Type DRUG

Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/PFS to be administered SC.

csDMARDs

Intervention Type DRUG

Stable dose of csDMARD(s) as SoC.

Placebo sequence 3

From Week 0-11: Placebo SC injection once weekly. From Week 12 onwards: Sarilumab 200 mg SC injection every other week + placebo SC injection in the intervening weeks. Participants will also receive a stable dose of csDMARD(s) as SoC.

Group Type PLACEBO_COMPARATOR

Sarilumab

Intervention Type BIOLOGICAL

Sarilumab solution in PFS to be administered SC.

Placebo to GSK3196165/ Sarilumab

Intervention Type DRUG

Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/PFS to be administered SC.

csDMARDs

Intervention Type DRUG

Stable dose of csDMARD(s) as SoC.

Interventions

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GSK3196165 (Otilimab)

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

Intervention Type BIOLOGICAL

Sarilumab

Sarilumab solution in PFS to be administered SC.

Intervention Type BIOLOGICAL

Placebo to GSK3196165/ Sarilumab

Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/PFS to be administered SC.

Intervention Type DRUG

csDMARDs

Stable dose of csDMARD(s) as SoC.

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 joints (tender joint count \[TJC\]), and
* \>=6/66 swollen joints (swollen joint count \[SJC\])
* Has had an inadequate response despite currently taking at least one and at the most two concomitant csDMARDs for at least 12 weeks, from the following:

* Methotrexate (MTX)
* Hydroxychloroquine or chloroquine
* Sulfasalazine
* Leflunomide
* Bucillamine
* Iguratimod
* Tacrolimus
* Has had inadequate response to at least one bDMARD at an approved dose and/or at least one JAK inhibitors at an approved dose. In both cases this may be with or without combination with a csDMARD.

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

Exclusion Criteria

* 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.
* Has known infection with human immunodeficiency virus (HIV) or current acute or chronic hepatitis B and/or hepatitis C.
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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GSK Investigational Site

Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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Covina, California, United States

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San Diego, California, United States

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Tujunga, California, United States

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Upland, California, United States

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Whittier, California, United States

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Brandon, Florida, United States

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DeBary, 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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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Newnan, Georgia, United States

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Chicago, Illinois, United States

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Skokie, Illinois, 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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Minot, North Dakota, United States

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Cincinnati, Ohio, United States

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Dayton, 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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Greenville, South Carolina, United States

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Austin, Texas, United States

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Baytown, Texas, United States

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College Station, Texas, United States

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Colleyville, 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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Plano, Texas, United States

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San Antonio, Texas, United States

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San Marcos, 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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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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La Palta, Buenos Aires, Argentina

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Mar del Plata, 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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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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San Juan, , Argentina

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Mons, , Belgium

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Barrie, Ontario, Canada

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Brampton, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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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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Uherské Hradiště, , Czechia

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Zlín, , Czechia

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Rendsburg, Schleswig-Holstein, Germany

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Hamburg, , Germany

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Magdeburg, , Germany

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Budapest, , Hungary

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Székesfehérvár, , Hungary

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Veszprém, , Hungary

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Verona, Veneto, Italy

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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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Fukuoka, , 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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Kagoshima, , Japan

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Kanagawa, , Japan

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Kochi, , Japan

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Kumamoto, , Japan

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Miyagi, , Japan

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Nagasaki, , Japan

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Saitama, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Klaipėda, , Lithuania

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Šiauliai, , Lithuania

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Gdansk, , Poland

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Gdynia, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Sochaczew, , 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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Wroclaw, , Poland

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Cape Town, , South Africa

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Kempton Park, , South Africa

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Pretoria, , South Africa

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Stellenbosch, , South Africa

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Incheon, , 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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A Coruña, , Spain

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Elche, , Spain

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Santander, , Spain

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Santiago de Compostela, , Spain

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Valencia, , Spain

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GSK Investigational Site

Romford, Essex, United Kingdom

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GSK Investigational Site

Northwood, Middlesex, United Kingdom

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Countries

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United States Argentina Belgium Canada Czechia Germany Hungary Italy Japan Lithuania Poland South Africa South Korea Spain United Kingdom

References

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Taylor PC, Weinblatt ME, McInnes IB, Atsumi T, Strand V, Takeuchi T, 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, Fleischmann RM. Anti-GM-CSF otilimab versus sarilumab or placebo in patients with rheumatoid arthritis and inadequate response to targeted therapies: a phase III randomised trial (contRAst 3). Ann Rheum Dis. 2023 Dec;82(12):1527-1537. doi: 10.1136/ard-2023-224449. Epub 2023 Sep 11.

Reference Type DERIVED
PMID: 37696589 (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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202018

Identifier Type: -

Identifier Source: org_study_id

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