To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

NCT ID: NCT01709578

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 546 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-03-31

Brief Summary

Primary Objective:

To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for:

• reduction of signs and symptoms at Week 24 and
• improvement of physical function at Week 12

in participants with active rheumatoid arthritis (RA) who were inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists.

Secondary Objectives:

The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in participants with active RA who were inadequate responders or intolerant to TNF-α antagonists, for:

• Reduction of signs and symptoms at Week 12;
• Improvement in physical function at Week 24;
• Improvement in disease activity score as measured by other American College of Rheumatology (ACR) derived components at Weeks 12 and 24;
• Improvement in quality of life as measured by participant reported outcomes (PROs) at intermediate visits and Week 24.

To assess the exposure of sarilumab added to DMARD therapy in this population.

To assess the safety of sarilumab in this population.

Detailed Description

Total study duration was up to 34 weeks: screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks.

After completion of the treatment phase of this study, participant were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).

Conditions

Rheumatoid Arthritis

Study Design

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

Study Groups

Placebo q2w

Placebo matched to sarilumab once every 2 weeks (q2w) was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

hydroxychloroquine

Intervention Type: DRUG

Dispensed according to the local practice.

methotrexate

Intervention Type: DRUG

Dispensed according to the local practice.

sulfasalazine

Intervention Type: DRUG

Dispensed according to the local practice.

leflunomide

Intervention Type: DRUG

Dispensed according to the local practice.

Sarilumab 150 mg q2w

Sarilumab 150 mg q2w was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.

Group Type: EXPERIMENTAL

Sarilumab

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

hydroxychloroquine

Intervention Type: DRUG

Dispensed according to the local practice.

methotrexate

Intervention Type: DRUG

Dispensed according to the local practice.

sulfasalazine

Intervention Type: DRUG

Dispensed according to the local practice.

leflunomide

Intervention Type: DRUG

Dispensed according to the local practice.

Sarilumab 200 mg q2w

Sarilumab 200 mg q2w was added to one or a combination of the nonbiologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide), except for simultaneous combination use of leflunomide and methotrexate for 24 weeks.

Group Type: EXPERIMENTAL

Sarilumab

Intervention Type: DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

hydroxychloroquine

Intervention Type: DRUG

Dispensed according to the local practice.

methotrexate

Intervention Type: DRUG

Dispensed according to the local practice.

sulfasalazine

Intervention Type: DRUG

Dispensed according to the local practice.

leflunomide

Intervention Type: DRUG

Dispensed according to the local practice.

Interventions

Sarilumab

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type: DRUG

placebo

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type: DRUG

hydroxychloroquine

Dispensed according to the local practice.

Intervention Type: DRUG

methotrexate

Dispensed according to the local practice.

Intervention Type: DRUG

sulfasalazine

Dispensed according to the local practice.

Intervention Type: DRUG

leflunomide

Dispensed according to the local practice.

Intervention Type: DRUG

Other Intervention Names

SAR153191; REGN88

Eligibility Criteria

Inclusion Criteria

Diagnosis of RA ≥6 months duration, according to the ACR /European League against Rheumatism (EULAR) 2010 RA Classification Criteria

ACR Class I-III functional status, based on 1991 revised criteria

Anti-TNF therapy failures, defined by the investigator as participants with an inadequate clinical response, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 anti-TNF blocker(s), resulting in or requiring their discontinuation:

• TNF-blockers included, but were not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab

Moderate-to-severely active RA

Continuous treatment with one or a combination of DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 weeks prior to baseline and on a stable dose(s) for at least 6 weeks prior to screening:

• Methotrexate - 6 to 25 mg/week orally or parenterally
• Leflunomide - 10 to 20 mg orally daily
• Sulfasalazine - 1000 to 3000 mg orally daily
• Hydroxychloroquine - 200 to 400 mg orally daily

Exclusion Criteria

Participants <18 years of age or legal adult age

Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA

History of juvenile idiopathic arthritis or arthritis onset prior to age 16

Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.

Treatment with anti-TNF agents, as follows:

• Within 28 days prior to the baseline visit - etanercept
• Within 42 days prior to the baseline visit - infliximab, adalimumab, golimumab, certolizumab pegol

Treatment with previous RA-directed biologic agents with other than TNF antagonist mechanisms:

Within 28 days prior to the randomization (baseline) visit - anakinra Within 42 days prior to the randomization (baseline) visit - abatacept

Within 6 months prior to the randomization (baseline) visit - any cell depleting agents including but not limited to rituximab without a normal lymphocyte and cluster of differentiation (CD) 19+ lymphocyte count

Treatment with any DMARD other than those allowed per protocol and limited to the maximum specified dosage within 12 weeks prior to baseline

Treatment with prednisone >10 mg or equivalent per day, or change in dosage within 4 weeks prior to baseline visit

Any parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline

Prior treatment with anti-interleukin (IL) -6 or IL-6 receptor antagonist therapies, including tocilizumab or sarilumab, participation in a prior study of sarilumab, irrespective of treatment arm

Prior treatment with a Janus kinase inhibitor (such as tofacitinib)

New treatment or dose-adjustment to ongoing medication for dyslipidemia within 6 weeks prior to randomization, ie, stable dose for at least 6 weeks prior to randomization

Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first investigational medicinal product (IMP) administration, whichever was longer

History of alcohol or drug abuse within 5 years prior to the screening visit

Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit. Nonmalignant lymphoproliferative disorders were also excluded

Participants with active tuberculosis or latent tuberculosis infection

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

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

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 032017

La Plata, , Argentina

Investigational Site Number 840070

Anniston, Alabama, United States

Investigational Site Number 840138

Birmingham, Alabama, United States

Investigational Site Number 840142

Phoenix, Arizona, United States

Investigational Site Number 840134

Fullerton, California, United States

Investigational Site Number 840141

Glendale, California, United States

Investigational Site Number 840111

La Jolla, California, United States

Investigational Site Number 840135

San Diego, California, United States

Investigational Site Number 840021

Santa Maria, California, United States

Investigational Site Number 840100

Stanford, California, United States

Investigational Site Number 840049

Upland, California, United States

Investigational Site Number 840131

Whittier, California, United States

Investigational Site Number 840201

Denver, Colorado, United States

Investigational Site Number 840130

Lewes, Delaware, United States

Investigational Site Number 840125

DeBary, Florida, United States

Investigational Site Number 840048

Miami, Florida, United States

Investigational Site Number 840024

Naples, Florida, United States

Investigational Site Number 840006

Orlando, Florida, United States

Investigational Site Number 840128

Ormond Beach, Florida, United States

Investigational Site Number 840063

Palm Harbor, Florida, United States

Investigational Site Number 840060

Sarasota, Florida, United States

Investigational Site Number 840140

Tampa, Florida, United States

Investigational Site Number 840126

Vero Beach, Florida, United States

Investigational Site Number 840018

Idaho Falls, Idaho, United States

Investigational Site Number 840110

Meridian, Idaho, United States

Investigational Site Number 840052

Kansas City, Kansas, United States

Investigational Site Number 840015

Lexington, Kentucky, United States

Investigational Site Number 840120

Baton Rouge, Louisiana, United States

Investigational Site Number 840109

Lake Charles, Louisiana, United States

Investigational Site Number 840055

Frederick, Maryland, United States

Investigational Site Number 840150

Lansing, Michigan, United States

Investigational Site Number 840137

Saint Clair Shores, Michigan, United States

Investigational Site Number 840037

Tupelo, Mississippi, United States

Investigational Site Number 840112

Lincoln, Nebraska, United States

Investigational Site Number 840106

Orchard Park, New York, United States

Investigational Site Number 840121

Rochester, New York, United States

Investigational Site Number 840115

Roslyn, New York, United States

Investigational Site Number 840118

Smithtown, New York, United States

Investigational Site Number 840139

Syracuse, New York, United States

Investigational Site Number 840123

Charlotte, North Carolina, United States

Investigational Site Number 840116

Wilmington, North Carolina, United States

Investigational Site Number 840127

Oklahoma City, Oklahoma, United States

Investigational Site Number 840011

Tulsa, Oklahoma, United States

Investigational Site Number 840009

Duncansville, Pennsylvania, United States

Investigational Site Number 840117

Pittsburgh, Pennsylvania, United States

Investigational Site Number 840062

Reading, Pennsylvania, United States

Investigational Site Number 840058

Columbia, South Carolina, United States

Investigational Site Number 840025

Jackson, Tennessee, United States

Investigational Site Number 840059

Memphis, Tennessee, United States

Investigational Site Number 840132

Austin, Texas, United States

Investigational Site Number 840022

Dallas, Texas, United States

Investigational Site Number 840114

El Paso, Texas, United States

Investigational Site Number 840133

Houston, Texas, United States

Investigational Site Number 840129

Houston, Texas, United States

Investigational Site Number 840074

Mesquite, Texas, United States

Investigational Site Number 840036

Spokane, Washington, United States

Investigational Site Number 840124

Clarksburg, West Virginia, United States

Investigational Site Number 032015

Buenos Aires, , Argentina

Investigational Site Number 032008

Buenos Aires, , Argentina

Investigational Site Number 032019

Caba, , Argentina

Investigational Site Number 032006

Caba, , Argentina

Investigational Site Number 032016

Capital Federal, , Argentina

Investigational Site Number 032020

Córdoba, , Argentina

Investigational Site Number 032010

Ramos Mejía, , Argentina

Investigational Site Number 032013

Rosario, , Argentina

Investigational Site Number 032004

San Miguel de Tucumán, , Argentina

Investigational Site Number 032009

Zárate, , Argentina

Investigational Site Number 036014

Victoria Park, , Australia

Investigational Site Number 040004

Stockerau, , Austria

Investigational Site Number 040003

Vienna, , Austria

Investigational Site Number 076001

Curitiba, , Brazil

Investigational Site Number 076016

Curitiba, , Brazil

Investigational Site Number 076006

Goiânia, , Brazil

Investigational Site Number 076010

Juiz de Fora, , Brazil

Investigational Site Number 076005

Rio de Janeiro, , Brazil

Investigational Site Number 076015

Rio de Janeiro, , Brazil

Investigational Site Number 124005

Toronto, , Canada

Investigational Site Number 124009

Trois-Rivières, , Canada

Investigational Site Number 124104

Victoria, , Canada

Investigational Site Number 152015

Temuco, , Chile

Investigational Site Number 170001

Bogotá, , Colombia

Investigational Site Number 170006

Bogotá, , Colombia

Investigational Site Number 170012

Bogotá, , Colombia

Investigational Site Number 170007

Bucaramanga, , Colombia

Investigational Site Number 170009

Bucaramanga, , Colombia

Investigational Site Number 170014

Chía, , Colombia

Investigational Site Number 170019

Medellín, , Colombia

Investigational Site Number 203008

Hostivice, , Czechia

Investigational Site Number 203004

Ostrava, , Czechia

Investigational Site Number 203007

Prague, , Czechia

Investigational Site Number 203002

Uherské Hradiště, , Czechia

Investigational Site Number 203006

Zlín, , Czechia

Investigational Site Number 218003

Cuenca, , Ecuador

Investigational Site Number 218001

Guayaquil, , Ecuador

Investigational Site Number 218002

Quito, , Ecuador

Investigational Site Number 276011

Bad Nauheim, , Germany

Investigational Site Number 276010

Berlin, , Germany

Investigational Site Number 276001

Berlin, , Germany

Investigational Site Number 276014

Berlin, , Germany

Investigational Site Number 276018

Deggingen, , Germany

Investigational Site Number 276004

Erlangen, , Germany

Investigational Site Number 276015

Halle, , Germany

Investigational Site Number 276013

Hamburg, , Germany

Investigational Site Number 276016

Leipzig, , Germany

Investigational Site Number 276017

München, , Germany

Investigational Site Number 276021

Osnabrück, , Germany

Investigational Site Number 276020

Tübingen, , Germany

Investigational Site Number 276019

Zerbst, , Germany

Investigational Site Number 300002

Heraklion, , Greece

Investigational Site Number 300005

Thessaloniki, , Greece

Investigational Site Number 320002

Guatemala City, , Guatemala

Investigational Site Number 320003

Guatemala City, , Guatemala

Investigational Site Number 320001

Guatemala City, , Guatemala

Investigational Site Number 348022

Budapest, , Hungary

Investigational Site Number 348003

Debrecen, , Hungary

Investigational Site Number 348004

Veszprém, , Hungary

Investigational Site Number 348017

Veszprém, , Hungary

Investigational Site Number 376001

Haifa, , Israel

Investigational Site Number 376003

Petah Tikva, , Israel

Investigational Site Number 376002

Tel Litwinsky, , Israel

Investigational Site Number 380011

Catania, , Italy

Investigational Site Number 380002

Florence, , Italy

Investigational Site Number 380005

Genova, , Italy

Investigational Site Number 380014

Milan, , Italy

Investigational Site Number 380013

Udine, , Italy

Investigational Site Number 440005

Kaunas, , Lithuania

Investigational Site Number 440006

Klaipėda, , Lithuania

Investigational Site Number 440007

Vilnius, , Lithuania

Investigational Site Number 484023

Chihuahua City, , Mexico

Investigational Site Number 484018

Guadalajara, , Mexico

Investigational Site Number 484002

Guadalajara, , Mexico

Investigational Site Number 484024

Guadalajara, , Mexico

Investigational Site Number 484010

Mexicali, , Mexico

Investigational Site Number 484017

México, , Mexico

Investigational Site Number 484019

Monterrey, , Mexico

Investigational Site Number 484020

Monterrey, , Mexico

Investigational Site Number 484005

Monterrey, , Mexico

Investigational Site Number 484021

Querétaro, , Mexico

Investigational Site Number 554005

Hamilton, , New Zealand

Investigational Site Number 554011

Nelson, , New Zealand

Investigational Site Number 554007

Otahuhu, , New Zealand

Investigational Site Number 554001

Timaru, , New Zealand

Investigational Site Number 554006

Wellington, , New Zealand

Investigational Site Number 604010

Lima, , Peru

Investigational Site Number 604009

Lima, , Peru

Investigational Site Number 604006

Lima, , Peru

Investigational Site Number 604012

Lima, , Peru

Investigational Site Number 604013

Lima, , Peru

Investigational Site Number 604001

Lima, , Peru

Investigational Site Number 604008

Lima, , Peru

Investigational Site Number 604007

Lima, , Peru

Investigational Site Number 604005

Lima, , Peru

Investigational Site Number 604014

Lima, , Peru

Investigational Site Number 616014

Bialystok, , Poland

Investigational Site Number 616019

Bydgoszcz, , Poland

Investigational Site Number 616015

Elblag, , Poland

Investigational Site Number 616018

Poznan, , Poland

Investigational Site Number 616016

Szczecin, , Poland

Investigational Site Number 616004

Warsaw, , Poland

Investigational Site Number 616017

Warsaw, , Poland

Investigational Site Number 616020

Wroclaw, , Poland

Investigational Site Number 620002

Lisbon, , Portugal

Investigational Site Number 620004

Lisbon, , Portugal

Investigational Site Number 620007

Ponte de Lima, , Portugal

Investigational Site Number 642001

Bucharest, , Romania

Investigational Site Number 642012

Bucharest, , Romania

Investigational Site Number 642002

Bucharest, , Romania

Investigational Site Number 642014

Iași, , Romania

Investigational Site Number 643001

Moscow, , Russia

Investigational Site Number 643021

Moscow, , Russia

Investigational Site Number 643022

Novosibirsk, , Russia

Investigational Site Number 643008

Saint Petersburg, , Russia

Investigational Site Number 643010

Samara, , Russia

Investigational Site Number 703001

Košice, , Slovakia

Investigational Site Number 410017

Daejeon, , South Korea

Investigational Site Number 410016

Seoul, , South Korea

Investigational Site Number 724009

A Coruña, , Spain

Investigational Site Number 724016

Barakaldo, , Spain

Investigational Site Number 724015

Barcelona, , Spain

Investigational Site Number 724014

Cadiz, , Spain

Investigational Site Number 724001

Málaga, , Spain

Investigational Site Number 724011

Sabadell, , Spain

Investigational Site Number 724017

Santiago de Compostela, , Spain

Investigational Site Number 724013

Santiago de Compostela, , Spain

Investigational Site Number 724007

Seville, , Spain

Investigational Site Number 158005

Kaohsiung City, , Taiwan

Investigational Site Number 158006

Taipei, , Taiwan

Investigational Site Number 158002

Taoyuan, , Taiwan

Investigational Site Number 792007

Edirne, , Turkey (Türkiye)

Investigational Site Number 792008

Gaziantep, , Turkey (Türkiye)

Investigational Site Number 792009

Samsun, , Turkey (Türkiye)

Investigational Site Number 804013

Kharkiv, , Ukraine

Investigational Site Number 804014

Kyiv, , Ukraine

Investigational Site Number 804027

Kyiv, , Ukraine

Investigational Site Number 804011

Vinnytsia, , Ukraine

Investigational Site Number 804009

Zaporizhzhya, , Ukraine

Countries

United States; Argentina; Australia; Austria; Brazil; Canada; Chile; Colombia; Czechia; Ecuador; Germany; Greece; Guatemala; Hungary; Israel; Italy; Lithuania; Mexico; New Zealand; Peru; Poland; Portugal; Romania; Russia; Slovakia; South Korea; Spain; Taiwan; Turkey (Türkiye); Ukraine

References

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Reference Type: RESULT

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Fleischmann R, Genovese MC, Maslova K, Leher H, Praestgaard A, Burmester GR. Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors. Rheumatology (Oxford). 2021 Nov 3;60(11):4991-5001. doi: 10.1093/rheumatology/keab355.

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Genovese MC, Fleischmann R, Kivitz A, Lee EB, van Hoogstraten H, Kimura T, St John G, Mangan EK, Burmester GR. Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies. Arthritis Res Ther. 2020 Jun 10;22(1):139. doi: 10.1186/s13075-020-02194-z.

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Gossec L, Strand V, Proudfoot C, Chen CI, Guillonneau S, Kimura T, van Hoogstraten H, Mangan E, Reaney M. Effects of Sarilumab on Rheumatoid Arthritis as Reported by Patients Using the Rheumatoid Arthritis Impact of Disease Scale. J Rheumatol. 2019 Oct;46(10):1259-1267. doi: 10.3899/jrheum.180904. Epub 2019 Mar 15.

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Gabay C, Msihid J, Zilberstein M, Paccard C, Lin Y, Graham NMH, Boyapati A. Identification of sarilumab pharmacodynamic and predictive markers in patients with inadequate response to TNF inhibition: a biomarker substudy of the phase 3 TARGET study. RMD Open. 2018 Mar 14;4(1):e000607. doi: 10.1136/rmdopen-2017-000607. eCollection 2018.

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Strand V, Reaney M, Chen CI, Proudfoot CW, Guillonneau S, Bauer D, Mangan E, Graham NM, van Hoogstraten H, Lin Y, Pacheco-Tena C, Fleischmann R. Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors. RMD Open. 2017 Mar 7;3(1):e000416. doi: 10.1136/rmdopen-2016-000416. eCollection 2017.

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Other Identifiers

U1111-1115-8466

Identifier Type: OTHER

Identifier Source: secondary_id

2011-003538-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC10832

Identifier Type: -

Identifier Source: org_study_id