Clinical trial NCT02760433: Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had Active Disease
Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-α) Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: moderate Rheumatoid Arthritis
severe Rheumatoid Arthritis
Olokizumab
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
name: OCT Clinical Trials
name: Mene Research
First posted: 2016-05-03
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving, but not fully responding to treatment with an existing medication called a tumour necrosis factor alpha inhibitor

The primary objective of this study was to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active rheumatoid arthritis (RA) inadequately controlled by TNF-α inhibitor (TNFi) therapy.

Detailed description: The goal of this Phase III study was to assess the efficacy, safety and tolerability of OKZ in subjects with moderately to severely active RA who had responded inadequately to TNFi therapy. The primary endpoint of the trial was assessed at Week 12. Olokizumab was expected to reduce the disease activity and improve physical function. The study was expected to provide safety information in a large group of subjects over at least a 24 week period.

This was a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. This study included a 4-week Screening Period, a double-blind Treatment Period from Week 0 to Week 24, and a Safety FollowUp Period from Week 24 to Week 44.

A total of 350 subjects were planned to be randomized.Subjects were assessed for eligibility to enter the study during a 4-week Screening Period. Eligible subjects were randomized at Visit 2 in a 2:2:1 ratio in one of 3 treatment groups (planned 140, 140, and 70 subjects per group, respectively) :

1. Olokizumab 64 mg q4w: SC injection of OKZ 64 mg q4w (alternating with SC injection of placebo OKZ q4w to maintain blinding) + MTX for 24 weeks,
2. Olokizumab 64 mg q2w: SC injection of OKZ 64 mg q2w + MTX for 24 weeks or
3. Placebo: SC injection of placebo q2w + MTX for 16 weeks.

Subjects who received placebo were re-randomized at Week 16 to receive 64 mg OKZ q4w + Methotrexate or 64 mg OKZ q2w +Methotrexate for 8 weeks.

Throughout the double-blind Treatment Period, all subjects were required to remain on a stable dose of background MTX with a stable route of administration. Concomitant treatment with folic acid was required for all subjects. The last dose of OKZ was administered at Week 20 for subjects receiving OKZ 64 mg q4w and at Week 22 for subjects receiving OKZ 64 mg q2w.

Following Visit 2 (randomization; Week 0), subjects returned to the study site at least every 2 weeks through Week 24 for response and safety assessments.

At Week 14, subjects who did not improve by at least 20% in both swollen and tender joint counts were classified as nonresponders and were administered sulfasalazine and/or hydroxychloroquine as rescue medication in addition to the assigned treatment.

After completion of the 24-week double-blind Treatment Period, subjects either rolled over into the long-term open-label extension (OLE) study or entered the Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for visits +4, +8, and +22 weeks after the last dose of study treatment.

Subjects who discontinued randomized treatment prematurely were required to come for the End of Treatment (EoT) Visit 2 weeks after the last study treatment administration and then continue with the scheduled study visits.

Adverse events (AEs) were assessed throughout the study (starting when the subject signed the informed consent form) and evaluated using the Common Terminology Criteria for Adverse Events Version 4.0. There was ongoing monitoring of safety events, including laboratory findings, by the Sponsor or the Sponsor's designee. In addition, safety was assessed throughout the study by an independent Data Safety Monitoring Board and potential major adverse cardiac events were evaluated by an independent Cardiovascular Adjudication Committee.

The study was conducted at 123 sites across 11 countries globally (in US,EU, Russian Federation, Asia, Latin America)

Eligibility criteria: Inclusion Criteria:

Subjects may be enrolled in the study only if they meet all of the following criteria.

* Subjects willing and able to sign informed consent
* Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 24 weeks prior to Screening.

(If the subject was diagnosed according to ACR 1987 criteria previously, the Investigator may classify the subject per ACR 2010 retrospectively, using available source data.)

* Treatment with oral, SC, or intramuscular (IM) MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses)

  * The dose and means of administering MTX must have been stable for at least 6 weeks prior to Screening.
* Subjects must be willing to take folic acid or equivalent throughout the study.
* Subjects must have moderately to severely active RA disease as defined by all of the following:

  * ≥6 tender joints (68 joint count) at Screening and baseline; and
  * ≥6 swollen joints (66 joint count) at Screening and baseline; and
  * C-reactive protein (CRP) above Upper limit of normal (ULN) at Screening based on the central laboratory results.
* Subjects must have a documented inadequate response to treatment (i.e., TNFi failure) with ≥1 licensed TNFi following at least 12 weeks of therapy with that agent. Inadequate response to treatment is classified as either:

  * Primary failure: The absence of any documented clinically significant response; or
  * Secondary failure: Documented initial response with subsequent loss of that response or partial response

Exclusion Criteria:

* Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus) (However, subjects may have secondary Sjogren's syndrome or hypothyroidism.)
* Subjects who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)
* Prior exposure to any licensed or investigational compound directly or indirectly targeting Interleukin (IL) 6 or IL 6R (including tofacitinib or other Janus kinases and spleen tyrosine kinase \[SYK\] inhibitors)
* Prior treatment with cell depleting therapies including anti CD20 or investigational agents (e.g., CAMPATH, anti CD4, anti CD5, anti CD3, and anti CD19) with the exception of rituximab, which is allowed if it was discontinued at least 24 weeks prior to baseline (rituximab should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA).
* Prior use of bDMARDs, within the following windows prior to baseline (bDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):

  1. 4 weeks for etanercept and anakinra
  2. 8 weeks for infliximab
  3. 10 weeks for adalimumab, certolizumab, and golimumab
  4. 12 weeks for abatacept
* Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline
* Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline
* Prior documented history of no response to hydroxychloroquine and sulfasalazine
* Prior use of cDMARDs (other than MTX) within the following windows prior to baseline (cDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):

  1. 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline
  2. 12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times daily for at least 24 hours
  3. 24 weeks for cyclophosphamide
* Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study
* Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline
* Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to baseline
* Use of intra-articular hyaluronic acid injections within 4 weeks prior to baseline
* Use of non steroidal anti inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline
* Previous participation in this study (randomized) or another study of OKZ
* Subjects with concurrent acute or chronic viral Hepatitis B or C infection as detected by blood tests at Screening (e.g., positive for hepatitis B surface antigen \[HBsAg\], total hepatitis B core antibody \[anti-HBc\], or hepatitis C virus antibody \[HCV Ab\])

  a) subjects who are positive for hepatitis B surface antibodies (anti-HBs), but negative for HBsAg and anti-HBc, will be eligible.
* Subjects with HIV infection
* Subjects with:

  1. Suspected or confirmed current active tuberculosis (TB) disease or a history of active TB disease.
  2. Close contact (i.e., sharing the same household or other enclosed environment, such as a social gathering place, workplace, or facility, for extended periods during the day) with an individual with active TB within 1.5 years prior to Screening
* Concurrent malignancy or a history of malignancy within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to Screening \[and no more than 3 excised skin cancers within the last 5 years prior to Screening\])
* Subjects with any infection requiring oral antibiotic or antiviral therapy in the 2 weeks prior to Screening or at baseline, injectable anti-infective therapy in the last 4 weeks prior to baseline, or serious or recurrent infection with history of hospitalization in the 6 months prior to baseline
* Subjects with evidence of disseminated herpes zoster infection, zoster encephalitis, meningitis, or other non-self-limited herpes zoster infections in the 6 months prior to baseline
* Subjects with planned surgery during the study or surgery ≤ 4 weeks prior to Screening and from which the subject has not fully recovered, as judged by the Investigator
* Subjects with diverticulitis or other symptomatic GI conditions that might predispose the subject to perforations, including subjects with history of such predisposing conditions (e.g., diverticulitis, GI perforation, or ulcerative colitis)
* Pre-existing central nervous system demyelinating disorders (e.g., multiple sclerosis and optic neuritis)
* History of chronic alcohol or drug abuse as judged by the Investigator
* Subjects with a known hypersensitivity to any component of the OKZ drug product or placebo
* Subjects with a known hypersensitivity or contraindication to any component of the rescue medication
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Female subjects who are pregnant, currently lactating, have lactated within the last 12 weeks, or who are planning to become pregnant during the study or within 6 months of the last dose of study treatment
* Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status \[e.g., correlative age\] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels \>40 mIU/mL and estradiol \<20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment

OR

Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment.

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

Primary outcomes:
measure: Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response
timeFrame: at Week 12
Secondary outcomes:
measure: Percentage of Subjects Achieving Low Disease Activity
timeFrame: at Week 12
measure: Improvement of Physical Ability From Baseline to Week 12, as Measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Baseline to Week 12
measure: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: at Week 12
measure: Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 (Remission)
timeFrame: at Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Hot Springs
country: United States
facility: CHI St. Vincent Hot Springs
state: Arkansas
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Fullerton
country: United States
facility: Saint Jude Heritage Medical Grp
state: California
city: Hemet
country: United States
facility: С V Mehta MD Med Corp.
state: California
city: Lakewood
country: United States
facility: Advanced Medical Research, LLC
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Riverside
country: United States
facility: Riverside Medical Clinic
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group, Inc.
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Newark
country: United States
facility: Javed Rheumatology Associates
state: Delaware
city: Boca Raton
country: United States
facility: RASF - Clinical Research Center
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group LLC
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Pembroke Pines
country: United States
facility: Family Clinical Trials, LLC.
state: Florida
city: Tampa
country: United States
facility: AdventHealth Medical Group, PA
state: Florida
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Monroe
country: United States
facility: The Arthritis & Diabetes Clinic, Inc.
state: Louisiana
city: Hagerstown
country: United States
facility: Klein and Associates, M.D., P.A.
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Kalispell
country: United States
facility: Glacier View Research Instutute-Rheumatology
state: Montana
city: Freehold
country: United States
facility: Arthritis & Osteoporosis Associates, PA
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc.
state: New Mexico
city: New York
country: United States
facility: NYU Langone Ambulatory Care
state: New York
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Minot
country: United States
facility: Trinity Medical Group
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group
state: Ohio
city: Dayton
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc.
state: Ohio
city: Philadelphia
country: United States
facility: Arthritis Group
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Research Center
state: South Carolina
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research
state: Texas
city: Austin
country: United States
facility: Austin Regional Clinic, P.A.
state: Texas
city: Baytown
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Grapevine
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts Rheumatology, LLC
state: Texas
city: Houston
country: United States
facility: Rheumatology Clinic of Houston, P.A.
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: League City
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Lubbock
country: United States
facility: Endocrinology, Internal Medicine
state: Texas
city: San Antonio
country: United States
facility: Dr. Alex De Jesus Rheumatology, P.A.
state: Texas
city: Woodville
country: United States
facility: Advanced Rheumatology of Houston
state: Texas
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes
state: Buenos Aires
city: Rosario
country: Argentina
facility: Clinica de Higado y Aparato Digestivo
state: Santa Fe
city: Venado Tuerto
country: Argentina
facility: Sanatorio San Martin
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Reumatológicas
state: Tucuman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Atencion Integral en Reumatologia (AIR)
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion (OMI)
city: Ciudad Autonoma Buenos aires
country: Argentina
facility: APRILLUS
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto Centenario
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba S.A
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Inv. Clinica CER
city: Fortaleza
country: Brazil
facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
state: Ceará
city: Vitória
country: Brazil
facility: CEDOES - Diagnóstico e Pesquisa
state: Espírito Santo
city: Goiânia
country: Brazil
facility: CIP - Centro Internacional de Pesquisa
state: Goiás
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa
state: Minas Gerais
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudos em Terapias Inovadoras Ltda.
state: Paraná
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: LMK Serviços Médicos S/S Ltda
state: Rio Grande Do Sul
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sao Paulo
city: Sao Bernardo Do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC
state: Sao Paulo
city: Santa Catarina
country: Brazil
facility: Clínica de Neoplasias Litoral Ltda.
city: Sao Paulo
country: Brazil
facility: Associação de Assistência à Criança Deficiente - AACD
city: São Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas Ltda.
city: Barranquilla
country: Colombia
facility: Centro de Reumatologia y Ortopedia SAS
city: Bogotá
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S.
city: Cali
country: Colombia
facility: Clinica de Artritis Temprana S.A.
city: Ostrava - Moravska Ostrava
country: Czechia
facility: Revmatologie MUDr. Klara Sirova s.r.o.
city: Pardubice
country: Czechia
facility: CCR Czech, a.s.
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Zlin
country: Czechia
facility: PV - Medical, s.r.o.
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
state: Hessen
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
state: Sachsen Anhalt
city: Hamburg
country: Germany
facility: HRF Hamburger Rheuma Forschungszentrum
city: Budapest
country: Hungary
facility: Clinexpert Egeszsegugyi Szolg. es Ker. Kft.
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum
city: Szolnok
country: Hungary
facility: MAV Korhaz és Rendelointezet
city: Veszprem
country: Hungary
facility: Vital Medical Center
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Mexico
country: Mexico
facility: Centro de Investigacion Clínica GRAMEL S.C
state: Distrito Federal
city: Mexico
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica SC
state: Jalisco
city: Monterrey
country: Mexico
facility: Accelerium S. de R.L. de C.V.
state: Nuevo León
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo León
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
state: San Luis Potos
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua, S.C.
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Grodzisk Mazowiecki
country: Poland
facility: McBk S.C.
city: Lodz
country: Poland
facility: Centrum Medyczne AMED
city: Sieradz
country: Poland
facility: Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego
city: Tomaszow Lubelski
country: Poland
facility: Samodzielny Publiczny ZOZ Tomaszow Lubelski
city: Warszawa
country: Poland
facility: McM Polimedica
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department
state: Moscow Region
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #1
state: Novosibirsk Oblast
city: Omsk
country: Russian Federation
facility: Diagnostic Center Ultramed
state: Omsk Oblast
city: Petrozavodsk
country: Russian Federation
facility: SBHI of the Republic of Karelia "Republican Hospital named after V.A.Baranov"
state: Republic Of Karelia
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical Unversity
state: Rostov Oblast
city: Stavropol'
country: Russian Federation
facility: SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"
state: Stavropol Region
city: Vladimir
country: Russian Federation
facility: Regional Clinical Hospital
state: Vladimir Oblast
city: Moscow
country: Russian Federation
facility: FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
Study officials:
affiliation: R-Pharm
name: Mikhail Samsonov
role: STUDY_DIRECTOR
References:
citation: Feist E, Fatenejad S, Grishin S, Korneva E, Luggen ME, Nasonov E, Samsonov M, Smolen JS, Fleischmann RM. Olokizumab, a monoclonal antibody against interleukin-6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by tumour necrosis factor inhibitor therapy: efficacy and safety results of a randomised controlled phase III study. Ann Rheum Dis. 2022 Dec;81(12):1661-1668. doi: 10.1136/ard-2022-222630. Epub 2022 Sep 15.