Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents (REASSURE)

A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)

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. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: Placebo; Biological: Secukinumab (AIN457)

Detailed Description

CAIN457F2302 (Core Study): Completed Sep 9 2015

CAIN457F2302E1 (Extension study): terminated early May 26 2015, ((unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.

• Study Type: Interventional
• Enrollment (Actual): 637
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1417EYG
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1114AAP
    • Novartis Investigative Site
  • Caba, Argentina, C1419AHN
    • Novartis Investigative Site
  • Ciudad Autonoma de Bs As, Argentina, C1428AZF
    • Novartis Investigative Site
  • Cordoba, Argentina, X5016KEH
    • Novartis Investigative Site
  • Tucuman, Argentina, 4000
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1181ACH
      • Novartis Investigative Site
    • Lanus, Buenos Aires, Argentina, B8000XAV
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000CFJ
      • Novartis Investigative Site
    • Rosario, Santa Fe, Argentina, S200BHD
      • Novartis Investigative Site
• Belgium
  • Bruxelles, Belgium, 1200
    • Novartis Investigative Site
  • Genk, Belgium, 3600
    • Novartis Investigative Site
  • Gent, Belgium, 9000
    • Novartis Investigative Site
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Novartis Investigative Site
  • Ontario
    • St. Catharines, Ontario, Canada, L2N 7E4
      • Novartis Investigative Site
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1v 3M7
      • Novartis Investigative Site
• Colombia
  • Bogotá, Colombia
    • Novartis Investigative Site
  • Bucaramanga, Colombia
    • Novartis Investigative Site
  • Medellín, Colombia
    • Novartis Investigative Site
• Guatemala
  • Guatemala City, Guatemala, 01010
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01011
    • Novartis Investigative Site
  • Guatemala City, Guatemala, 01015
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, 1023
    • Novartis Investigative Site
  • Budapest, Hungary, 1062
    • Novartis Investigative Site
  • Eger, Hungary, 3300
    • Novartis Investigative Site
  • Gyula, Hungary, 5700
    • Novartis Investigative Site
  • Szekesfehervar, Hungary, H-8000
    • Novartis Investigative Site
  • Szolnok, Hungary, 5000
    • Novartis Investigative Site
  • Veszprem, Hungary, H-8200
    • Novartis Investigative Site
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500004
      • Novartis Investigative Site
  • Delhi
    • New Delhi, Delhi, India, 110 060
      • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • Novartis Investigative Site
    • Bangalore, Karnataka, India, 560043
      • Novartis Investigative Site
  • Maharashtra
    • Amravati, Maharashtra, India, 444606
      • Novartis Investigative Site
    • Mumbai, Maharashtra, India, 400 053
      • Novartis Investigative Site
    • Pune, Maharashtra, India, 411 007
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  • Rajasthan
    • Ajmer, Rajasthan, India, 305 001
      • Novartis Investigative Site
    • Jaipur, Rajasthan, India, 320013
      • Novartis Investigative Site
  • Telangana
    • Secunderabad, Telangana, India, 500003
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• Italy
  • CT
    • Catania, CT, Italy, 95100
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  • FI
    • Firenze, FI, Italy, 50134
      • Novartis Investigative Site
  • MN
    • Pieve di Coriano, MN, Italy, 46020
      • Novartis Investigative Site
  • SI
    • Siena, SI, Italy, 53100
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  • VR
    • Verona, VR, Italy, 37100
      • Novartis Investigative Site
• Japan
  • Fukuoka, Japan, 810-8563
    • Novartis Investigative Site
  • Aichi
    • Nagoya, Aichi, Japan, 460-0001
      • Novartis Investigative Site
    • Nagoya-city, Aichi, Japan, 466-8560
      • Novartis Investigative Site
  • Chiba
    • Chiba-city, Chiba, Japan, 260-0801
      • Novartis Investigative Site
    • Yotsukaido-city, Chiba, Japan, 284-0003
      • Novartis Investigative Site
  • Fukuoka
    • Fukuoka-city, Fukuoka, Japan, 813-0017
      • Novartis Investigative Site
    • Iizuka-city, Fukuoka, Japan, 820-8505
      • Novartis Investigative Site
    • Kitakyushu-city, Fukuoka, Japan, 807-8556
      • Novartis Investigative Site
  • Gunma
    • Takasaki-city, Gunma, Japan, 370-0053
      • Novartis Investigative Site
  • Hiroshima
    • Hiroshima-city, Hiroshima, Japan, 733-0032
      • Novartis Investigative Site
  • Hokkaido
    • Sapporo-city, Hokkaido, Japan, 060-0001
      • Novartis Investigative Site
    • Sapporo-city, Hokkaido, Japan, 063-0811
      • Novartis Investigative Site
  • Kanagawa
    • Kamakura-city, Kanagawa, Japan, 247-8533
      • Novartis Investigative Site
    • Kawasaki-city, Kanagawa, Japan, 210-0013
      • Novartis Investigative Site
    • Sagamihara-city, Kanagawa, Japan, 228-8522
      • Novartis Investigative Site
    • Yokohama-city, Kanagawa, Japan, 231-8682
      • Novartis Investigative Site
  • Kumamoto
    • Kumamoto-city, Kumamoto, Japan, 862-0976
      • Novartis Investigative Site
  • Miyagi
    • Taihaku-ku, Miyagi, Japan, 982-0032
      • Novartis Investigative Site
  • Nagano
    • Nagano-city, Nagano, Japan, 380-8582
      • Novartis Investigative Site
  • Nagasaki
    • Nagasaki-city, Nagasaki, Japan, 852-8501
      • Novartis Investigative Site
    • Sasebo-city, Nagasaki, Japan, 857-1165
      • Novartis Investigative Site
  • Okayama
    • Kurashiki-city, Okayama, Japan, 710-0016
      • Novartis Investigative Site
    • Okayama-city, Okayama, Japan, 700-8511
      • Novartis Investigative Site
    • Tsukubo-gun, Okayama, Japan, 701-0304
      • Novartis Investigative Site
  • Osaka
    • Hannan-city, Osaka, Japan, 599-0212
      • Novartis Investigative Site
    • Kawachinagano-city, Osaka, Japan, 586-8521
      • Novartis Investigative Site
    • Osaka-city, Osaka, Japan, 545-8586
      • Novartis Investigative Site
  • Saitama
    • Kawagoe, Saitama, Japan, 350-1103
      • Novartis Investigative Site
    • Tokorozawa-city, Saitama, Japan, 359-1111
      • Novartis Investigative Site
  • Shizuoka
    • Fuji-city, Shizuoka, Japan, 417-0045
      • Novartis Investigative Site
    • Hamamatsu-city, Shizuoka, Japan, 430-8558
      • Novartis Investigative Site
  • Tokyo
    • Fuchu, Tokyo, Japan, 183-8524
      • Novartis Investigative Site
    • Itabashi-ku, Tokyo, Japan, 174-0071
      • Novartis Investigative Site
    • Setagaya-ku, Tokyo, Japan, 156-0052
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160-0054
      • Novartis Investigative Site
  • Toyama
    • Takaoka-city, Toyama, Japan, 933-0874
      • Novartis Investigative Site
    • Toyama-city, Toyama, Japan, 930-0138
      • Novartis Investigative Site
  • Yamaguchi
    • Shimonoseki-city, Yamaguchi, Japan, 752-0976
      • Novartis Investigative Site
• Mexico
  • Baja California
    • Mexicali, Baja California, Mexico, 21100
      • Novartis Investigative Site
    • Mexicali, Baja California, Mexico, 21200
      • 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
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80000
      • Novartis Investigative Site
• Panama
  • Panamá
    • Panama City, Panamá, Panama, 0823-01510
      • Novartis Investigative Site
    • Panama City, Panamá, Panama
      • Novartis Investigative Site
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Novartis Investigative Site
  • San Juan, Puerto Rico, 00909
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
  • Chiang Mai, Thailand, 50200
    • Novartis Investigative Site
  • Songkla, Thailand, 90110
    • Novartis Investigative Site
  • THA
    • Bangkok, THA, Thailand, 10330
      • Novartis Investigative Site
    • Khon Kaen, THA, Thailand, 40002
      • Novartis Investigative Site
• Turkey
  • Ankara, Turkey, 06100
    • Novartis Investigative Site
• United Kingdom
  • Salisbury, United Kingdom, SP2 8BJ
    • Novartis Investigative Site
  • London
    • Leytonstone, London, United Kingdom, E11 1NR
      • Novartis Investigative Site
  • Staffordshire
    • Cannock, Staffordshire, United Kingdom, WS11 2XY
      • Novartis Investigative Site
• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Novartis Investigative Site
    • Paradise Valley, Arizona, United States, 85253
      • Novartis Investigative Site
    • Peoria, Arizona, United States, 85381
      • Novartis Investigative Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Novartis Investigative Site
  • California
    • Santa Monica, California, United States, 90404
      • Novartis Investigative Site
    • Stanford, California, United States, 94305
      • Novartis Investigative Site
    • Torrance, California, United States, 90502
      • Novartis Investigative Site
    • Upland, California, United States, 91786
      • Novartis Investigative Site
  • Florida
    • Hialeah, Florida, United States, 33016
      • Novartis Investigative Site
    • Largo, Florida, United States, 33773
      • Novartis Investigative Site
    • Miami, Florida, United States, 33169
      • Novartis Investigative Site
    • Orlando, Florida, United States, 32806
      • Novartis Investigative Site
    • Palm Harbor, Florida, United States, 34684
      • Novartis Investigative Site
    • South Miami, Florida, United States, 33143
      • Novartis Investigative Site
    • Tamarac, Florida, United States, 33321
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33612
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33614-7118
      • Novartis Investigative Site
  • Georgia
    • Canton, Georgia, United States, 30114
      • Novartis Investigative Site
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Novartis Investigative Site
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • Novartis Investigative Site
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Novartis Investigative Site
  • Missouri
    • Kansas City, Missouri, United States, 66160-7330
      • Novartis Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Novartis Investigative Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Novartis Investigative Site
    • Charlotte, North Carolina, United States, 28210
      • Novartis Investigative Site
    • Durham, North Carolina, United States, 27704
      • Novartis Investigative Site
  • Ohio
    • Gallipolis, Ohio, United States, 45631
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Novartis Investigative Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15237
      • Novartis Investigative Site
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Novartis Investigative Site
    • Greenville, South Carolina, United States, 29601
      • Novartis Investigative Site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Novartis Investigative Site
    • Johnson City, Tennessee, United States, 37604
      • Novartis Investigative Site
    • Nashville, Tennessee, United States, 37205
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75390
      • Novartis Investigative Site
    • Houston, Texas, United States, 77034
      • Novartis Investigative Site
    • Houston, Texas, United States, 77074
      • Novartis Investigative Site
    • Mesquite, Texas, United States, 75150
      • Novartis Investigative Site
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • 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 American College of Rheumatology (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 (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 mm/1st hr
• 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 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 Japan only: 6 to 25 mg/week)

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 including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
• 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
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AIN457 10mg/kg-75mg; 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: Secukinumab (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: AIN457
EXPERIMENTAL: AIN457 10mg/kg-150mg; 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: Secukinumab (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: AIN457
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24	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
Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70		up to week 260

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core Study: Change From Baseline and Week 24 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
Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score	Separate radiographs of each hand/wrist and each foot were taken at basline and Week 24. The radiographs were assessed using the van der Heijde modified Sharp score. The change in the Van der Heijde modified Sharp score is calculated against the baseline value. The total van der Heide modified Sharp score goes from 0 to 448, the bigger the change, the worse it is for the patient.	Week 24
Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52	The major clinical response is defined as continuous six-month period of ACR70 response during the 1 year period. ACR70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 70% 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 ACR70 response results at week 24 used non-responder imputation.	52 week
Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28)	The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health. Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6.	week 260
Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (EULAR) Responses	Low Disease Activity is defined as DAS28 ≤ 3.2. EULAR good response requires an improvement of > 1.2 in the DAS28 score with a present score of ≤3.2; EULAR moderate response is defined as an improvement of >0.6 to ≤1.2 in DAS28 and a present score of ≤5.1; or an improvement of >1.2 and a present score of >3.2.	up to week 260
Extension Phase: Proportion of Subjects Achieving ACR/(EULAR) Remission	ACR/EULAR remission is defined as SDAI ≤ 3.3, where SDAI is a measure of disease activity in RA based on 28 tender and swollen joint counts, CRP, Physician and Patient's Global Assessments of Disease	up to week 260
Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2	Short Form Health Survey (SF-36) consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed.	Baseline, up to week 260
Extension Phase: Immunogenicity Against Secukinumab		up to week 260

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.
• Tahir H, Deodhar A, Genovese M, Takeuchi T, Aelion J, Van den Bosch F, Haemmerle S, Richards HB. Secukinumab in Active Rheumatoid Arthritis after Anti-TNFalpha Therapy: A Randomized, Double-Blind Placebo-Controlled Phase 3 Study. Rheumatol Ther. 2017 Dec;4(2):475-488. doi: 10.1007/s40744-017-0086-y. Epub 2017 Nov 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2011
• Primary Completion (ACTUAL): September 9, 2015
• Study Completion (ACTUAL): September 9, 2015

Study Registration Dates

• First Submitted: June 17, 2011
• First Submitted That Met QC Criteria: June 17, 2011
• First Posted (ESTIMATE): June 20, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

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
• Other Study ID Numbers: CAIN457F2302/E1; 2011-000275-13 (EUDRACT_NUMBER)