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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2011
End Date:September 2015

Use our guide to learn which trials are right for you!

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.

This study will assess the safety and efficacy of secukinumab when added to a background
therapy in patients with active rheumatoid arthritis (RA) who are intolerant to or have had
an inadequate response to anti-tumor necrosis factor (TNF)-α agents.


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.
We found this trial at
43
sites
Asheville, North Carolina 28803
859
mi
from
Asheville, NC
Click here to add this to my saved trials
Bowling Green, Kentucky 42101
624
mi
from
Bowling Green, KY
Click here to add this to my saved trials
Caba, Buenos Aires
5602
mi
from
Caba,
Click here to add this to my saved trials
Canton, Georgia 30114
782
mi
from
Canton, GA
Click here to add this to my saved trials
Charlotte, North Carolina 28277
962
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28277
962
mi
from
Charlotte, NC
Click here to add this to my saved trials
Columbia, South Carolina 29201
973
mi
from
Columbia, SC
Click here to add this to my saved trials
Dallas, Texas 75216
353
mi
from
Dallas, TX
Click here to add this to my saved trials
Durham, North Carolina 27710
1048
mi
from
Durham, NC
Click here to add this to my saved trials
Eagan, Minnesota 55121
546
mi
from
Eagan, MN
Click here to add this to my saved trials
Gallipolis, Ohio 45631
849
mi
from
Gallipolis, OH
Click here to add this to my saved trials
Greenville, South Carolina 29605
883
mi
from
Greenville, SC
Click here to add this to my saved trials
Hialeah, Florida 33012
1312
mi
from
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77030
572
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
572
mi
from
Houston, TX
Click here to add this to my saved trials
Jackson, Tennessee 38305
520
mi
from
Jackson, TN
Click here to add this to my saved trials
Johnson City, Tennessee 37604
858
mi
from
Johnson City, TN
Click here to add this to my saved trials
Kansas City, Missouri 64111
196
mi
from
Kansas City, MO
Click here to add this to my saved trials
Largo, Florida 33773
1106
mi
from
Largo, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89135
960
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Little Rock, Arkansas 72204
368
mi
from
Little Rock, AR
Click here to add this to my saved trials
Mesa, Arizona 85205
835
mi
from
Mesa, AZ
Click here to add this to my saved trials
Mesa, Arizona 85205
835
mi
from
Mesa, AZ
Click here to add this to my saved trials
Mesquite, Texas 75150
346
mi
from
Mesquite, TX
Click here to add this to my saved trials
Miami, Florida 33136
1320
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37205
615
mi
from
Nashville, TN
Click here to add this to my saved trials
Orlando, Florida 32806
1144
mi
from
Orlando, FL
Click here to add this to my saved trials
Palm Harbor, Florida 34684
1099
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Paradise Valley, Arizona 85253
843
mi
from
Paradise Valley, AZ
Click here to add this to my saved trials
Paradise Valley, Arizona 85253
843
mi
from
Paradise Valley, AZ
Click here to add this to my saved trials
Peoria, Arizona 85381
856
mi
from
Peoria, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
974
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1385
mi
from
Portland, OR
Click here to add this to my saved trials
Salt Lake City, Utah 84103
779
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Santa Monica, California 90404
1181
mi
from
Santa Monica, CA
Click here to add this to my saved trials
South Miami, Florida 33143
1320
mi
from
South Miami, FL
Click here to add this to my saved trials
Stanford, California 94305
1329
mi
from
Stanford, CA
Click here to add this to my saved trials
Tamarac, Florida 33321
1298
mi
from
Tamarac, FL
Click here to add this to my saved trials
Tampa, Florida 33613
1111
mi
from
Tampa, FL
Click here to add this to my saved trials
Tampa, Florida 33613
1111
mi
from
Tampa, FL
Click here to add this to my saved trials
Torrance, California 90502
1176
mi
from
Torrance, CA
Click here to add this to my saved trials
Upland, California 91786
1135
mi
from
Upland, CA
Click here to add this to my saved trials
Wheaton, Maryland 20902
1126
mi
from
Wheaton, MD
Click here to add this to my saved trials