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) (NURTURE 1)

A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: AIN457; Biological: Placebo; Biological: Abatacept

• Study Type: Interventional
• Enrollment (Actual): 551
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • PR
    • Curitiba, PR, Brazil, 80060-900
      • Novartis Investigative Site
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22271-100
      • Novartis Investigative Site
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Novartis Investigative Site
  • SP
    • Sao Paulo, SP, Brazil, 04266-010
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 05403-000
      • Novartis Investigative Site
    • São Paulo, SP, Brazil, 04023-900
      • Novartis Investigative Site
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Novartis Investigative Site
  • Plovdiv, Bulgaria, 4000
    • Novartis Investigative Site
  • Russe, Bulgaria, 7000
    • Novartis Investigative Site
  • Sevlievo, Bulgaria
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1431
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1505
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1612
    • Novartis Investigative Site
• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
      • Novartis Investigative Site
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1W 4R4
      • Novartis Investigative Site
    • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
      • Novartis Investigative Site
• Colombia
  • Barranquilla, Colombia
    • Novartis Investigative Site
  • Bogotá, Colombia, 110221
    • Novartis Investigative Site
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia
      • Novartis Investigative Site
• Czech Republic
  • Bruntal, Czech Republic, 792 01
    • Novartis Investigative Site
  • Ostrava, Czech Republic, 772 00
    • Novartis Investigative Site
  • Uherske Hradiste, Czech Republic, 686 01
    • Novartis Investigative Site
  • Zlin, Czech Republic, 760 01
    • Novartis Investigative Site
• France
  • Bordeaux Cedex, France, 33076
    • Novartis Investigative Site
  • Cahors, France, 46005
    • Novartis Investigative Site
  • Montpellier, France, 34195
    • Novartis Investigative Site
  • Paris, France, 75014
    • Novartis Investigative Site
  • Toulouse, France, 31059
    • Novartis Investigative Site
• Germany
  • Aachen, Germany, 52064
    • Novartis Investigative Site
  • Berlin, Germany, 10117
    • Novartis Investigative Site
  • Berlin, Germany, 14059
    • Novartis Investigative Site
  • Cottbus, Germany, 03042
    • Novartis Investigative Site
  • Erlangen, Germany, 91056
    • Novartis Investigative Site
  • Essen, Germany, 45276
    • Novartis Investigative Site
  • Gommern, Germany, 39245
    • Novartis Investigative Site
  • Hamburg, Germany, 22415
    • Novartis Investigative Site
  • Hamburg, Germany, 22147
    • Novartis Investigative Site
  • Koeln, Germany, 50924
    • Novartis Investigative Site
  • Leipzig, Germany, 04103
    • Novartis Investigative Site
  • Magdeburg, Germany, 39110
    • Novartis Investigative Site
  • Osnabrück, Germany, 49074
    • Novartis Investigative Site
  • Zerbst, Germany, 39261
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, 1023
    • Novartis Investigative Site
  • Budapest, Hungary, 1062
    • Novartis Investigative Site
  • Gyor, Hungary, 9023
    • Novartis Investigative Site
  • Gyula, Hungary, 5700
    • Novartis Investigative Site
  • Szolnok, Hungary, 5000
    • Novartis Investigative Site
• Italy
  • (vr)
    • Valeggio Sul Mincio, (vr), Italy, 37067
      • Novartis Investigative Site
  • FI
    • Firenze, FI, Italy, 50139
      • Novartis Investigative Site
  • GE
    • Genova, GE, Italy, 16132
      • Novartis Investigative Site
  • PG
    • Perugia, PG, Italy, 06100
      • Novartis Investigative Site
  • SI
    • Siena, SI, Italy, 53100
      • Novartis Investigative Site
• Mexico
  • Baja California
    • Mexicali, Baja California, Mexico, 21100
      • Novartis Investigative Site
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06700
      • Novartis Investigative Site
    • Mexico, Distrito Federal, Mexico, 11850
      • Novartis Investigative Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Novartis Investigative Site
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64020
      • Novartis Investigative Site
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80000
      • Novartis Investigative Site
• Romania
  • Iasi, Romania, 700195
    • Novartis Investigative Site
• Russian Federation
  • Korolev, Russian Federation, 141060
    • Novartis Investigative Site
  • Moscow, Russian Federation, 115522
    • Novartis Investigative Site
  • Petrozavodsk, Russian Federation, 185019
    • Novartis Investigative Site
  • Saint-Petersburg, Russian Federation, 197341
    • Novartis Investigative Site
  • Tula, Russian Federation, 300053
    • Novartis Investigative Site
• Slovakia
  • Piestany, Slovakia, 92112
    • Novartis Investigative Site
  • Slovak Republic
    • Banska Bystrica, Slovak Republic, Slovakia, 975 17
      • Novartis Investigative Site
• Spain
  • Madrid, Spain, 28046
    • Novartis Investigative Site
  • Andalucia
    • Malaga, Andalucia, Spain, 29010
      • Novartis Investigative Site
    • Sevilla, Andalucia, Spain, 41009
      • Novartis Investigative Site
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Novartis Investigative Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Novartis Investigative Site
  • Galicia
    • La Coruna, Galicia, Spain, 15006
      • Novartis Investigative Site
    • Santiago de Compostela, Galicia, Spain, 15706
      • Novartis Investigative Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207-5710
      • Novartis Investigative Site
    • Vestavia, Alabama, United States, 35216
      • Novartis Investigative Site
  • California
    • Freemont, California, United States, 94538
      • Novartis Investigative Site
    • Pomona, California, United States, 91767
      • Novartis Investigative Site
    • Upland, California, United States, 91786
      • Novartis Investigative Site
    • Van Nuys, California, United States, 91405
      • Novartis Investigative Site
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Novartis Investigative Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Novartis Investigative Site
    • Boca Raton, Florida, United States, 33486
      • Novartis Investigative Site
    • Hialeah, Florida, United States, 33012
      • Novartis Investigative Site
    • Miami, Florida, United States, 33126
      • Novartis Investigative Site
    • Orlando, Florida, United States, 32806
      • Novartis Investigative Site
    • Palm Harbor, Florida, United States, 34684
      • Novartis Investigative Site
    • Pembroke Pines, Florida, United States, 33026
      • Novartis Investigative Site
    • Pensacola, Florida, United States, 32514
      • Novartis Investigative Site
    • Plantation, Florida, United States, 33324
      • Novartis Investigative Site
    • Sarasota, Florida, United States, 34239
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33603
      • Novartis Investigative Site
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Novartis Investigative Site
  • Illinois
    • Morton Grove, Illinois, United States, 60053
      • Novartis Investigative Site
    • Springfield, Illinois, United States, 62704
      • Novartis Investigative Site
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Novartis Investigative Site
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Novartis Investigative Site
    • Lexington, Kentucky, United States, 40615
      • Novartis Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Novartis Investigative Site
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Novartis Investigative Site
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Novartis Investigative Site
  • Missouri
    • Kansas City, Missouri, United States, 66160-7330
      • Novartis Investigative Site
    • Richmond Heights, Missouri, United States, 63117
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Novartis Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Novartis Investigative Site
    • Zanesville, Ohio, United States, 43701
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Novartis Investigative Site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Novartis Investigative Site
    • Kingsport, Tennessee, United States, 37660
      • Novartis Investigative Site
  • Texas
    • Austin, Texas, United States, 78731
      • Novartis Investigative Site
    • Carrollton, Texas, United States, 75010
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75216
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75204
      • Novartis Investigative Site
    • Houston, Texas, United States, 77034
      • Novartis Investigative Site
    • Sugar Land, Texas, United States, 77479
      • Novartis Investigative Site
    • Waco, Texas, United States, 76710
      • Novartis Investigative Site
  • Washington
    • Spokane, Washington, United States, 99204
      • Novartis Investigative Site
  • West Virginia
    • Clarksburg, West Virginia, United States, 26301
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: 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.; Other Names: Secukinumab
Experimental: 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	Biological: 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.; Other Names: Secukinumab
Placebo Comparator: 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.	Biological: 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.; Other Names: Secukinumab; 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.
Active Comparator: 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).	Biological: 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.; Other Names: Secukinumab; 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.; Other Names: Orencia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).	ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)	The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.	baseline, week 24
Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)	The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.	baseline, week 24
Percentage of Participants Achieving ACR50	ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation.	week 24
Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation	ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).	baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24
Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data	ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20, ACR50 and ACR70 response results from baseline up to week 52 were based on observed data, i.e. without imputation.	baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM)	The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.	baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change From Baseline in HAQ-DI - Observed Data	The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The HAQ-DI results from baseline up to week 52 were based on observed data, i.e. without imputation.	baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM	The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.	baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24
Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data	The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement. The DAS28-CRP results from baseline up to week 52 were based on observed data, i.e. without imputation.	baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change From Baseline in hsCRP - Observed Data	Blood samples were obtained to identify the presence of inflammation, to determine its severity and to monitor response to treatment. A negative change from baseline indicates improvement. The hsCRP results from baseline up to week 52 were based on observed data, i.e. without imputation.	baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data	Blood samples were obtained to monitor disease activity and response to treatment. A negative change from baseline indicates improvement. The ESR results from baseline up to week 52 were based on observed data, i.e. without imputation.	baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Estimate): May 23, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; RA; ACR; inflammatory joints
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Abatacept
• Other Study ID Numbers: CAIN457F2309; 2011-000102-21 (EudraCT Number)