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Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Secukinmab

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA, ACR, inflammatory joints

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (> or =7.5 mg/week - < or = 25 mg/week) for at least 4 weeks
At Baseline: Disease activity criteria defined by > or = 6 out of 28 tender joints and > or = 6 out of 28 swollen joints WITH either Screening value of hsCRP > or = 10 mg/L OR ESR > or = 28 mm/1st hr

Exclusion Criteria:

RA patients functional status class IV classified according to the ACR 1991 revised criteria
Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization

Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Secukinumab 25mg

Secukinumab 75mg

Secukinumab 150mg

Secukinumab 300mg

Secukinumab Placebo

Arm Description

Secukinumab 25mg s.c. q4wk

Secukinumab 75mg s.c. q4wk

Secukinumab 150mg s. c. q4wk

Secukinumab 300mg s.c. q4wk

Secukinumab Placebo s.c. q4wk

Outcomes

Primary Outcome Measures

Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks

A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire [HAQ©] score)and acute phase rectant (C-reactive protein [hsCRP]/ESR).

Secondary Outcome Measures

Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16

A participant was considered as improved according to the ACR50 or ACR70 criteria if he/she had at least a 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient self-assessed disability (Health Assessment Questionnaire [HAQ©] score) and Acute phase reactant (C-reactive protein [hsCRP]/ESR). Participants were defined as ACR50/70 responders at a given post-randomization visit if they satisfied the ACR50/70 criteria, respectively. Participants were considered ACR50/70 nonresponders if they failed the ACR50/70 criteria respectively. Participants who prematurely discontinued from study due to insufficient therapeutic effect were also considered nonresponders.

Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16

A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if he/she had as least a 20%, 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assessed disability and acute phase rectant or Erythrocyte sedimentation rate (ESR).

Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)

The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient's 'global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission. The DAS28-CRP was derived from swollen joint count, tender joint count, hsCRP and patient's global assessment of disease activity.

Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)

The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) which can be aggregated to derive a physical-component summary score and a mental-component score. Scores are normally determined with the use of norm-based methods which standardize scores based on an assessment of the general U.S. population free of chronic conditions. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with the higher scores indicative of better health.

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16

The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue©) is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeThe scale score was computed by summing the item scores, after reversing those items that were worded in the negative direction. When there were missing item scores, the subscale score was computed by summing the non-missing item scores, multiplying by 13 (the total number of items in the scale) and dividing by the number of non-missing items. The latter rule applied only when at least half of the items (seven or more) were non-missing. FACIT-Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.

Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16

The distribution of EULAR response criteria was according to DAS28-CRP at Week 16. EULAR response criteria are based on DAS28-CRP status in combination with DAS28-CRP improvements. The EULAR response criteria are as follows: Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement >1.2 corresponds to 'good response'; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement between 0.6 to 1.2, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement >1.2 or from 0.6 to 1.2, or WeeK 16 DAS28-CRP >5.1 with DAS28-CRP improvement >1.2 correspond to 'moderate response; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP >5.1 with DAS28-CRP improvement between 0.6 to 1.2 or <0.6 correspond to 'no response'.

Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16

Only values that were above normal range (12 U/mL) were were included.

Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16

Only values that were above normal range (20 units) were included.

Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16

Synovial fluid and/or soft tissue swelling but not bony overgrowth represents a positive result for swollen joint count. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. Whenever possible, the same evaluator performed these assessments at all visits. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., S) was less than 28, the number of swollen joints (e.g., s) was scaled up proportionately (i.e., 28*(s/S)).

Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16

The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient's 'global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission.The DAS28 was also derived using erythrocyte sedimentation rate (ESR) (referred to as DAS28-ESR).

Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16

The ACR tender joint count (28 joints) was done by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., T) was less than 28, the number of tender joints (e.g., t) was scaled up proportionately (i.e., 28*(t/T)).

Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16

The patient's assessment of pain was performed at all visits using 100 mm visual analog scale (VAS) ranging from "no pain" to "unbearable pain" after the question "Please indicate with a vertical mark ( | ) through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours.

Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16

The patient's global assessment of disease activity was performed at the visits on a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, "Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing".

Change From Baseline in ACR Component: Physician's Global Assessment of Disease Activity at Week 16

The physician's global assessment of disease activity was performed at the visits usingon a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, "Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing".

Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16

HAQ© was used to assess physical ability and functional status of patients as well as quality of life at the visits in these 8 categories assessed by the Disability Index: dressing & grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Patients report amount of difficulty they have in performing 2 or 3 specific activities. There are 4 possible responses (0, 1, 2, 3) for these questions which include types of assistance, if any; the participant uses for his/her usual activities: 0: without any difficulty- No assistance is needed; 1: with some difficulty - A special device is used by the patient in his/her usual activities; 2: with much difficulty - The patient usually needs help from another person. 3: Unable to do - the patient usually needs both a special device and help from another person. Scores of 0 - 1 are generally considered to represent mild to moderate difficulty, 1-2 moderate to severe disability, and 2 -3 severe to very severe disability.

Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP)

Blood for this assessment was obtained at the visits in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.Since the results of this test may have unblinded study personnel, results from the central lab were provided for screening and baseline only. The hsCRP results from samples collected during the treatment period were revealed only after final database lock.

Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16

Blood for ESR, which is helpful to diagnose inflammatory diseases and to monitor disease activity and response to therapy, was obtained at the visits.

Full Information

NCT ID

NCT00928512

First Posted

June 25, 2009

Last Updated

October 7, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00928512

Brief Title

Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

Official Title

A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab (AIN457) Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, RA, ACR, inflammatory joints

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

237 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secukinumab 25mg

Arm Type

Experimental

Arm Description

Secukinumab 25mg s.c. q4wk

Arm Title

Secukinumab 75mg

Arm Type

Experimental

Arm Description

Secukinumab 75mg s.c. q4wk

Arm Title

Secukinumab 150mg

Arm Type

Experimental

Arm Description

Secukinumab 150mg s. c. q4wk

Arm Title

Secukinumab 300mg

Arm Type

Experimental

Arm Description

Secukinumab 300mg s.c. q4wk

Arm Title

Secukinumab Placebo

Arm Type

Placebo Comparator

Arm Description

Secukinumab Placebo s.c. q4wk

Intervention Type

Drug

Intervention Name(s)

Secukinmab

Other Intervention Name(s)

AIN457

Intervention Description

Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.

Primary Outcome Measure Information:

Title

Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks

Description

Time Frame

16cweeks

Secondary Outcome Measure Information:

Title

Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16

Description

Time Frame

Week 16

Title

Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16

Description

Time Frame

at Weeks2, 4, 8, 12, 16

Title

Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)

Description

Time Frame

Baseline, week 16

Title

Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)

Description

Time Frame

Baseline, week 16

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16

Description

Time Frame

Week 16

Title

Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16

Description

Only values that were above normal range (12 U/mL) were were included.

Time Frame

Baseline, Week 16

Title

Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16

Description

Only values that were above normal range (20 units) were included.

Time Frame

Baseline, Week 16

Title

Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16

Description

Time Frame

Baseline, week 16

Title

Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16

Description

The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient's 'global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission.The DAS28 was also derived using erythrocyte sedimentation rate (ESR) (referred to as DAS28-ESR).

Time Frame

Baseline, week 16

Title

Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16

Description

Time Frame

Baseline, week 16

Title

Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16

Description

Time Frame

Baseline, week 16

Title

Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16

Description

Time Frame

Baseline, week 16

Title

Change From Baseline in ACR Component: Physician's Global Assessment of Disease Activity at Week 16

Description

Time Frame

Baseline, week 16

Title

Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16

Description

Time Frame

Baseline, week 16

Title

Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP)

Description

Time Frame

Baseline, week 16

Title

Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16

Description

Blood for ESR, which is helpful to diagnose inflammatory diseases and to monitor disease activity and response to therapy, was obtained at the visits.

Time Frame

Baseline, week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (> or =7.5 mg/week - < or = 25 mg/week) for at least 4 weeks At Baseline: Disease activity criteria defined by > or = 6 out of 28 tender joints and > or = 6 out of 28 swollen joints WITH either Screening value of hsCRP > or = 10 mg/L OR ESR > or = 28 mm/1st hr Exclusion Criteria: RA patients functional status class IV classified according to the ACR 1991 revised criteria Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine) Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

Novartis Investigative Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Novartis Investigative Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Novartis Investigative Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Novartis Investigative Site

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Novartis Investigative Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49048

Country

United States

Facility Name

Novartis Investigative Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Novartis Investigative Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135-2920

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Novartis Investigative Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Ostrava

ZIP/Postal Code

72200

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Pardubice

ZIP/Postal Code

53002

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Praha 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

Novartis Investigative Site

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80639

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Iizuka-city

State/Province

Fukuoka

ZIP/Postal Code

820-8505

Country

Japan

Facility Name

Novartis Investigative Site

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

650-0044

Country

Japan

Facility Name

Novartis Investigative Site

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

658-0011

Country

Japan

Facility Name

Novartis Investigative Site

City

Sagamihara-city

State/Province

Kanagawa

ZIP/Postal Code

228-8522

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

710-8522

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawagoe

State/Province

Saitama

ZIP/Postal Code

350-1103

Country

Japan

Facility Name

Novartis Investigative Site

City

Anyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-337

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-461

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-607

Country

Poland

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

117049

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

129327

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St-Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St-Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St.Petersburg

ZIP/Postal Code

194104

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Tula

ZIP/Postal Code

300053

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Tver

ZIP/Postal Code

170036

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

040 15

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Piestany

State/Province

Slovak Republic

ZIP/Postal Code

921 12

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Taichung

State/Province

Taiwan ROC

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

81346

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Niaosong Township

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

24429175

Citation

Genovese MC, Durez P, Richards HB, Supronik J, Dokoupilova E, Aelion JA, Lee SH, Codding CE, Kellner H, Ikawa T, Hugot S, Ligozio G, Mpofu S. One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study. J Rheumatol. 2014 Mar;41(3):414-21. doi: 10.3899/jrheum.130637. Epub 2014 Jan 15.

Results Reference

derived

PubMed Identifier

22730366

Citation

Genovese MC, Durez P, Richards HB, Supronik J, Dokoupilova E, Mazurov V, Aelion JA, Lee SH, Codding CE, Kellner H, Ikawa T, Hugot S, Mpofu S. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study. Ann Rheum Dis. 2013 Jun;72(6):863-9. doi: 10.1136/annrheumdis-2012-201601. Epub 2012 Jun 23.

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Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

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Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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