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Trial information
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis.
Status: Recruiting
Protocol number: ML21136
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double blind, parallel group study to evaluate the effect of tocilizumab versus placebo in reducing the signs and symptoms of rheumatoid arthritis in combination with DMARDs in patients with moderate to severe active rheumatoid arthritis
Brief summary: This 2 arm study will assess the safety and efficacy, with regard to reduction in signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with moderate to severe active rheumatoid arthritis, with an inadequate response to DMARDs. Patients will be randomized in a ratio of 2:1 to receive either tocilizumab 8mg/kg iv or placebo iv every 4 weeks; all patients will also receive stable antirheumatic therapy including permitted DMARDs. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 570.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: tocilizumab
Primary outcome: 1. Number and percentage of patients with ACR 50 response Time frame: Week 24
Key secondary outcomes: 1. Number and percentage of patients with ACR 20/50/70, and mean change from baseline in DAS 28, RAPID, SF-12, FACIT-F, MOS sleep scale. Time frame: Week 24
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria: - adult patients, >=18 years of age;
- active rheumatoid arthritis of >6 months duration;
- receiving permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline.
Exclusion criteria: - rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- major surgery within 8 weeks prior to screening or planned within 6 months following randomization;
- unsuccessful treatment with a biologic agent, including an anti-TNF agent;
- previous treatment with tocilizumab.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2007
Trial registration date: 09/17/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:United States - Birmingham, AL
- Montgomery, AL
- Lake Havasu City, AZ
- Paradise Valley, AZ
- Peoria, AZ
- Scottsdale, AZ
- Jonesboro, AR
- Beverly Hills, CA
- Escondido, CA
- Fountain Valley, CA
- La Jolla, CA
- Long Beach, CA
- Los Angeles, CA
- Pasadena, CA
- Santa Maria, CA
- Santa Monica, CA
- Upland, CA
- Van Nuys, CA
- Walnut Creek, CA
- Whittier, CA
- Aurora, CO
- Colorado Springs, CO
- Trumbull, CT
- Washington, DC
- Dunedin, FL
- Fort Lauderdale, FL
- Gainesville, FL
- Lake Mary, FL
- Melbourne, FL
- Miami, FL
- Ocala, FL
- Orange Park, FL
- Orlando, FL
- Plantation, FL
- Sarasota , FL
- Tamarac, FL
- Tampa, FL
- Atlanta, GA
- Blue Ridge, GA
- Fort Valley, GA
- Tifton, GA
- Boise, ID
- Idaho Falls, ID
- Nampa, ID
- Downers Grove, IL
- Springfield, IL
- Evansville, IN
- Munster, IN
- South Bend, IN
- Leawood, KS
- Bowling Green, KY
- Lexington, KY
- Baton Rouge, LA
- Monroe, LA
- New Orleans, LA
- Wheaton, MD
- Mansfield, MA
- Worcester, MA
- Ann Arbor, MI
- Kalamazoo, MI
- St Clair Shores, MI
- Eagan, MN
- Flowood, MS
- Tupelo, MS
- Florissant, MO
- St Louis, MO
- Billings, MT
- Kalispell, MT
- Missoula, MT
- Grand Island, NE
- Las Vegas, NV
- Reno , NV
- Dover, NH
- Manalapan, NJ
- New Brunswick, NJ
- Passaic, NJ
- Teaneck, NJ
- Bronx, NY
- Mineola, NY
- New York, NY
- Orchard Park, NY
- Smithtown, NY
- Belmont, NC
- Charlotte, NC
- Durham, NC
- Greensboro, NC
- Greenville, NC
- Hickory , NC
- Rock Hill, NC
- Akron, OH
- Beechwood, OH
- Mayfield, OH
- Middleburg Heights, OH
- Perryburg, OH
- Zanesville, OH
- Norman, OK
- Oklahoma City, OK
- Portland, OR
- Salem, OR
- Bethlehem, PA
- Philadelphia, PA
- Pittsburgh, PA
- Wexford, PA
- San Antonio, PR
- San Juan, PR
- Charleston, SC
- Columbia, SC
- Florence, SC
- Myrtle Beach, SC
- Simpsonville, SC
- Rapid City, SD
- Sioux Falls, SD
- Watertown, SD
- Crossville, TN
- Hendersonville, TN
- Jackson, TN
- Knoxville, TN
- Memphis , TN
- Nashville, TN
- Amarillo, TX
- Bellaire, TX
- Carrollton, TX
- Dallas, TX
- Fort Worth, TX
- Houston, TX
- Mesquite, TX
- San Antonio, TX
- Temple, TX
- Waco, TX
- Webster, TX
- Ogden, UT
- Salt Lake City, UT
- Burlington, VT
- Burke, VA
- Reston, VA
- Salem, VA
- Seattle, WA
- Spokane , WA
- Beckley, WV
- Clarksburg, WV
- Milwaukee, WI
- Onalaska, WI
- Wausau, WI
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