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A Study on the Impact of Methotrexate Discontinuation on the Efficacy of Subcutaneous RoActemra/Actemra (Tocilizumab) With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: methotrexate (Drug); placebo (Drug); tocilizumab [RoActemra/Actemra] (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Overall contact:
Reference Study ID Number: ML28776 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Summary

This randomized, multicenter, double-blind, parallel group study will evaluate the impact of methotrexate (MTX) discontinuation on the efficacy of subcutaneous RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Patients will be initiated on RoActemra/Actemra 162 mg weekly or every 2 weeks, remaining on a stable dose of MTX. At Week 24, patients achieving a disease activity score (DAS28)

Clinical Details

Official title: A RANDOMIZED, DOUBLE-BLIND TRIAL ASSESSING THE IMPACT OF METHOTREXATE DISCONTINUATION ON THE EFFICACY OF SUBCUTANEOUS TOCILIZUMAB WITH METHOTREXATE THERAPY

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in disease activity (DAS28) scores

Secondary outcome:

Change in bone erosion scores for patients in the MRI substudy

Percentage of patients with a >/= 1.2 worsening in DAS28 between Week 24 and Weeks 40 and 52

Percentage of patients achieving DAS 28 <2.6 and DAS28 Percentage of patients achieving ACR20/50/70 responses at Weeks 40 and 52

Safety: Incidence of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Body weight

- Active moderate to severe rheumatoid arthritis (DAS28 >/= 4. 4) according to the

revised 1987 ACR criteria at screening and baseline (prior to treatment Day 1)

- Currently receiving oral MTX for at least 24 weeks and on a stable dose of at least

15 mg/week for at least 6 weeks prior to treatment (Day 1), with the following exception: a stable dose of at least 10 mg/week is allowed for patients with a body weight < 50 kg or calculated glomerular filtration rate (or creatinine clearance) < 60 mL/min

- History of parenteral (subcutaneous or intramuscular) MTX is allowed, but not within

6 weeks prior to treatment (Day 1)

- Prior to enrollment, will have discontinued etanercept for >/= 2 weeks, infliximab,

certolizumab, adalimumab, or golimumab for >/= 8 weeks

- Oral corticosteroids must have been stable for at least 25 out of 28 days prior to treatment (Day 1)

- Patients receiving treatment on an outpatient basis

Exclusion Criteria:

- Documented medical history of significant intolerance to oral MTX >/= 15 mg/week

- Patients receiving other (non-MTX) disease modifying anti-rheumatic drugs (DMARDs)

within 8 weeks of screening

- Previous treatment with abatacept, rituximab, tofacitinib, or anakinra

- Treatment with intrarticular or parenteral corticosteroids within 4 weeks prior to

treatment

- Previous treatment with cell-depleting therapies or alkylating agents

- Previous treatment with RoActemra/Actemra (tocilizumab)

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned

surgery within 12 months following randomization

- Rheumatic autoimmune disease other than rheumatoid arthritis

- Non-rheumatic autoimmune diseases (e. g. inflammatory bowel diseases, psoriasis,

multiple sclerosis)

- Prior history of or current inflammatory joint disease other than rheumatoid

arthritis

- Functional class IV according to the revised (1987) ACR criteria for rheumatoid

arthritis

- History of severe allergic or anaphylactic reactions to human, humanized, or murine

monoclonal antibodies

- Evidence of significant uncontrolled concomitant diseases; uncontrolled disease

states where flares are commonly treated with oral or parenteral corticosteroids

- Active current or history of recurrent infection, or any major episode of infection

requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening

- Active tuberculosis requiring treatment within the previous 3 years

- History of or currently active primary or secondary immunodeficiency

- Pregnant or breast-feeding women

- Positive for hepatitis B or hepatitis C infection

- For potential MRI substudy patients: the presence of any metal-containing device or

object in the body.

Locations and Contacts

Reference Study ID Number: ML28776 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com

Anniston, Alabama 36207, United States; Recruiting

Birmingham, Alabama 35294, United States; Recruiting

Huntsville, Alabama 35801, United States; Recruiting

Tuscaloosa, Alabama 35406, United States; Recruiting

Glendale, Arizona 85306, United States; Recruiting

Mesa, Arizona 85202, United States; Recruiting

Paradise Valley, Arizona 85253, United States; Recruiting

Phoenix, Arizona 85027, United States; Recruiting

Phoenix, Arizona 85037, United States; Recruiting

Scottsdale, Arizona 85258, United States; Recruiting

Tucson, Arizona 85712, United States; Not yet recruiting

Fort Smith, Arkansas 72903, United States; Recruiting

Hot Springs, Arkansas 71913, United States; Recruiting

Jonesboro, Arkansas 72401, United States; Recruiting

Little Rock, Arkansas 72205, United States; Recruiting

Covina, California 91723, United States; Recruiting

El Cajon, California 92020, United States; Recruiting

Fullerton, California 92835, United States; Recruiting

Hemet, California 92543, United States; Recruiting

Long Beach, California 90806, United States; Recruiting

Orange, California 92868, United States; Recruiting

San Diego, California 92108, United States; Recruiting

San Leandro, California 94578, United States; Recruiting

Upland, California 91786, United States; Recruiting

Whittier, California 90606, United States; Recruiting

Aurora, Colorado 80045, United States; Recruiting

Colorado Springs, Colorado 80920, United States; Recruiting

Denver, Colorado 80230-7127, United States; Recruiting

Bridgeport, Connecticut 06606, United States; Recruiting

Danbury, Connecticut 06810, United States; Recruiting

Hamden, Connecticut 06518, United States; Recruiting

Trumbull, Connecticut 06611, United States; Recruiting

Lewes, Delaware 19958, United States; Recruiting

Newark, Delaware 19713, United States; Recruiting

Aventura, Florida 33180, United States; Recruiting

Dunedin, Florida 34698, United States; Recruiting

Miami Lakes, Florida 33016, United States; Recruiting

Miami, Florida 33136, United States; Recruiting

Miami, Florida 33135, United States; Recruiting

Naples, Florida 34102, United States; Recruiting

Orlando, Florida 32806, United States; Recruiting

Orlando, Florida 32836, United States; Recruiting

Orlando, Florida 34761, United States; Recruiting

Palm Habor, Florida 34684, United States; Recruiting

Palm Harbor, Florida 34684, United States; Recruiting

Sarasota, Florida 34239, United States; Recruiting

St. Petersburg, Florida 33708, United States; Recruiting

Tamarac, Florida 33321, United States; Recruiting

Tampa, Florida 33614, United States; Recruiting

Tampa, Florida 33613, United States; Recruiting

Duluth, Georgia 30096, United States; Recruiting

Gainesville, Georgia 30501, United States; Recruiting

Lawrenceville, Georgia 30046, United States; Recruiting

Idaho Falls, Idaho 83404, United States; Recruiting

Springfield, Illinois 62703, United States; Recruiting

Indianapolis, Indiana 46202, United States; Recruiting

Indianapolis, Indiana 46227, United States; Recruiting

Lexington, Kentucky 40515, United States; Recruiting

Monroe, Louisiana 71203, United States; Recruiting

Hagerstown, Maryland 21740, United States; Recruiting

Wheaton, Maryland 20902, United States; Recruiting

Boston, Massachusetts 02111, United States; Completed

Fall River, Massachusetts 02720, United States; Recruiting

Mansfield, Massachusetts 02048, United States; Recruiting

Worcester, Massachusetts 01605, United States; Recruiting

Worcester, Massachusetts 01610, United States; Recruiting

Lansing, Michigan 48910, United States; Completed

Lansing, Michigan 48910, United States; Recruiting

Petoskey, Michigan 49770, United States; Recruiting

St. Claire Shores, Michigan 48081, United States; Recruiting

Duluth, Minnesota 55805, United States; Recruiting

Eagan, Minnesota 55121, United States; Recruiting

Flowood, Mississippi 39232, United States; Recruiting

Florissant, Missouri 63031, United States; Recruiting

Kansas CIty, Missouri 64111, United States; Recruiting

Lee's Summit, Missouri 64086, United States; Recruiting

Saint Louis, Missouri 63117, United States; Recruiting

Saint Louis, Missouri 63141, United States; Recruiting

Las Vegas, Nevada 89128, United States; Recruiting

Lebabon, New Hampshire 03756, United States; Recruiting

Nashua, New Hampshire 03060, United States; Recruiting

Manalapan, New Jersey 07726, United States; Recruiting

Toms River, New Jersey 08755, United States; Recruiting

Toms River, New Jersey 08775, United States; Recruiting

Voorhees, New Jersey 08043, United States; Recruiting

Albuquerque, New Mexico 87102, United States; Recruiting

Las Cruces, New Mexico 88011, United States; Recruiting

Brooklyn, New York 11201, United States; Recruiting

Manhasset, New York 11030, United States; Recruiting

New York, New York 10016, United States; Recruiting

Orchard Park, New York 14127, United States; Recruiting

Plainview, New York 11803, United States; Recruiting

Smithtown, New York 11787, United States; Recruiting

Syracuse, New York 13210, United States; Recruiting

Asheville, North Carolina 28803, United States; Recruiting

Charlotte, North Carolina 28210, United States; Recruiting

Durham, North Carolina 27704, United States; Recruiting

Greensboro, North Carolina 27408, United States; Recruiting

Hickory, North Carolina 28602, United States; Recruiting

Leland, North Carolina 28451, United States; Recruiting

Raleigh, North Carolina 27617, United States; Recruiting

Bismarck, North Dakota 58501, United States; Recruiting

Bismark, North Dakota 58507, United States; Recruiting

Akron, Ohio 44333, United States; Recruiting

Cincinnati, Ohio 45219, United States; Recruiting

Cleveland, Ohio 44109, United States; Recruiting

Columbus, Ohio 43203, United States; Recruiting

Columbus, Ohio 43215, United States; Recruiting

Dayton, Ohio 45417, United States; Recruiting

Middleburg Heights, Ohio 44130, United States; Recruiting

Toledo, Ohio 43606, United States; Recruiting

Ardmore, Oklahoma 73401, United States; Recruiting

Oklahoma City, Oklahoma 73103, United States; Recruiting

Oklahoma City, Oklahoma 73112, United States; Recruiting

Tulsa, Oklahoma 74104, United States; Recruiting

Tulsa, Oklahoma 74135, United States; Recruiting

Portland, Oregon 97225, United States; Recruiting

Duncansville, Pennsylvania 16635, United States; Recruiting

Erie, Pennsylvania 16508, United States; Recruiting

Philadelphia, Pennsylvania 19152, United States; Recruiting

Wexford, Pennsylvania 15090, United States; Recruiting

Wyomissing, Pennsylvania 19610, United States; Recruiting

Charleston, South Carolina 29406, United States; Recruiting

Columbia, South Carolina 29204, United States; Recruiting

Greenville, South Carolina 29601, United States; Recruiting

Jackson, Tennessee 38305, United States; Recruiting

Memphis, Tennessee 38119, United States; Recruiting

Amarillo, Texas 79124, United States; Recruiting

Austin, Texas 78731, United States; Recruiting

Austin, Texas 78758, United States; Recruiting

Beaumont, Texas 77701, United States; Recruiting

College Station, Texas 77845, United States; Recruiting

Corpus Christi, Texas 78404, United States; Recruiting

Dallas, Texas 75231-4406, United States; Recruiting

Dallas, Texas 75231, United States; Recruiting

Houston, Texas 77004, United States; Recruiting

Houston, Texas 77007, United States; Completed

Houston, Texas 77074, United States; Recruiting

Houston, Texas 77034, United States; Recruiting

Mesquite, Texas 75150, United States; Recruiting

San Antonio, Texas 78217, United States; Not yet recruiting

San Antonio, Texas 78229, United States; Recruiting

San Antonio, Texas 78232, United States; Recruiting

San Marcos, Texas 78666, United States; Recruiting

Victoria, Texas 77901, United States; Recruiting

Waco, Texas 76708, United States; Recruiting

Olympia, Washington 98502, United States; Recruiting

Spokane, Washington 99204, United States; Recruiting

Wenatchee, Washington 98801, United States; Recruiting

Clarksburg, West Virginia 26301, United States; Terminated

Glendale, Wisconsin 53217, United States; Recruiting

Manitowoc, Wisconsin 54220, United States; Recruiting

Onalaska, Wisconsin 54605, United States; Terminated

Additional Information

Starting date: November 2013
Last updated: August 17, 2015

Page last updated: August 20, 2015

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