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Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)

NCT ID: NCT01350804

Last Updated: 2016-05-23

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

551 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-02-28

Brief Summary

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The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AIN457 10mg/kg - 75 mg

Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks

Group Type EXPERIMENTAL

AIN457

Intervention Type BIOLOGICAL

AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.

AIN457 10mg/kg - 150 mg

Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks

Group Type EXPERIMENTAL

AIN457

Intervention Type BIOLOGICAL

AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.

Placebo

Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.

Group Type PLACEBO_COMPARATOR

AIN457

Intervention Type BIOLOGICAL

AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.

Placebo

Intervention Type BIOLOGICAL

Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.

Abatacept

Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).

Group Type ACTIVE_COMPARATOR

AIN457

Intervention Type BIOLOGICAL

AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.

Abatacept

Intervention Type BIOLOGICAL

Abatacept (from 500 to 1000 mg i.v. based on weight) was given as i.v. at baseline, weeks 2 and 4, and then every 4 weeks starting at week 8.

Interventions

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AIN457

AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.

Intervention Type BIOLOGICAL

Placebo

Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.

Intervention Type BIOLOGICAL

Abatacept

Abatacept (from 500 to 1000 mg i.v. based on weight) was given as i.v. at baseline, weeks 2 and 4, and then every 4 weeks starting at week 8.

Intervention Type BIOLOGICAL

Other Intervention Names

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Secukinumab Orencia

Eligibility Criteria

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Inclusion Criteria

* Male or non-pregnant, non-lactating female patients
* Presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
* At Baseline: Disease activity criteria defined by \>= 6 tender joints out of 68 and \>= 6 swollen joints out of 66

WITH at least 1 of the following at screening:

* Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR
* Rheumatoid Factor positive

AND WITH at least 1 of the following at screening:

* High sensitivity C-Reactive Protein (hsCRP) \>= 10 mg/L OR
* Erythrocyte Sedimentation Rate (ESR) \>= 28 millimeter (mm)/1st hour
* Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent
* Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated dose)

Exclusion Criteria

* Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
* RA patients functional status class IV according to the ACR 1991 revised criteria
* Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
* Previous treatment with any cell-depleting therapies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Anniston, Alabama, United States

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Vestavia Hills, Alabama, United States

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Freemont, California, United States

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Pomona, California, United States

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Upland, California, United States

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Van Nuys, California, United States

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Bridgeport, Connecticut, United States

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Aventura, Florida, United States

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Boca Raton, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Pensacola, Florida, United States

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Plantation, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Coeur d'Alene, Idaho, United States

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Morton Grove, Illinois, United States

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Springfield, Illinois, United States

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Wichita, Kansas, United States

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Bowling Green, Kentucky, United States

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Lexington, Kentucky, United States

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Boston, Massachusetts, United States

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Lansing, Michigan, United States

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Eagan, Minnesota, United States

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Kansas City, Missouri, United States

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Richmond Heights, Missouri, United States

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Omaha, Nebraska, United States

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Cincinnati, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Jackson, Tennessee, United States

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Kingsport, Tennessee, United States

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Austin, Texas, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Sugar Land, Texas, United States

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Waco, Texas, United States

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Spokane, Washington, United States

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Clarksburg, West Virginia, United States

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Curitiba, Paraná, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Plovdiv, Bulgaria, Bulgaria

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Plovdiv, Bulgaria, Bulgaria

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Rousse, Bulgaria, Bulgaria

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Sevlievo, Bulgaria, Bulgaria

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Sofia, Bulgaria, Bulgaria

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Sofia, Bulgaria, Bulgaria

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Sofia, Bulgaria, Bulgaria

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St. John's, Newfoundland and Labrador, Canada

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Sainte-Foy, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Bogotá, Cundinamarca, Colombia

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Bruntál, Czech Republic, Czechia

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Ostrava, Czech Republic, Czechia

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Uherské Hradiště, Czech Republic, Czechia

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Zlín, Czech Republic, Czechia

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Bordeaux, , France

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Cahors, , France

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Montpellier, , France

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Paris, , France

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Toulouse, , France

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Aachen, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Cottbus, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Gommern, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Magdeburg, , Germany

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Osnabrück, , Germany

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Zerbst, , Germany

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Győr, Hungary, Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Gyula, , Hungary

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Szolnok, , Hungary

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Valeggio sul Mincio, (vr), Italy

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Florence, FI, Italy

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Genova, GE, Italy

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Perugia, PG, Italy

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Siena, SI, Italy

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Mexicali, Estado de Baja California, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Culiacán, Sinaloa, Mexico

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Iași, Iaşi, Romania

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Korolyov, , Russia

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Moscow, , Russia

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Petrozavodsk, , Russia

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Saint Petersburg, , Russia

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Tula, , Russia

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Banská Bystrica, Slovak Republic, Slovakia

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Piešťany, Slovakia, Slovakia

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Sabadell, Barcelona, Spain

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Santander, Cantabria, Spain

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A Coruña, Galicia, Spain

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Santiago de Compostela, Galicia, Spain

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Madrid, Madrid, Spain

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Countries

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United States Brazil Bulgaria Canada Colombia Czechia France Germany Hungary Italy Mexico Romania Russia Slovakia Spain

References

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Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.

Reference Type DERIVED
PMID: 31087226 (View on PubMed)

Blanco FJ, Moricke R, Dokoupilova E, Codding C, Neal J, Andersson M, Rohrer S, Richards H. Secukinumab in Active Rheumatoid Arthritis: A Phase III Randomized, Double-Blind, Active Comparator- and Placebo-Controlled Study. Arthritis Rheumatol. 2017 Jun;69(6):1144-1153. doi: 10.1002/art.40070. Epub 2017 May 3.

Reference Type DERIVED
PMID: 28217871 (View on PubMed)

Other Identifiers

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2011-000102-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457F2309

Identifier Type: -

Identifier Source: org_study_id

NCT01640938

Identifier Type: -

Identifier Source: nct_alias

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