Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis
NCT ID: NCT00634933
Last Updated: 2013-03-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
222 participants
INTERVENTIONAL
2008-03-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Consists of Arms 1a and 1b
TRU-015
IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).
Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).
Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms)
Arm 2
Consists of Arms 2a and 2b
TRU-015
IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).
Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).
Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms).
Arm 3
Consists of Arms 3a and 3b.
TRU-015
IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b).
Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b).
Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).
Interventions
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TRU-015
IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).
Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).
Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms)
TRU-015
IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).
Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).
Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms).
TRU-015
IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b).
Methylprednisolone
IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b).
Prednisone
Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any significant health problem other than rheumatoid arthritis
* Clinically significant laboratory abnormalities
18 Years
ALL
No
Sponsors
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Trubion Pharmaceuticals/Emergent BioSolutions Inc.
UNKNOWN
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Paradise Valley, Arizona, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Santa Maria, California, United States
Pfizer Investigational Site
Santa Monica, California, United States
Pfizer Investigational Site
Daytona Beach, Florida, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
Palm Harbor, Florida, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Springfield, Illinois, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
Grande Rapids, Michigan, United States
Pfizer Investigational Site
Flowood, Mississippi, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Syracuse, New York, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Minot, North Dakota, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Mayfield Village, Ohio, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Danville, Pennsylvania, United States
Pfizer Investigational Site
State College, Pennsylvania, United States
Pfizer Investigational Site
Wexford, Pennsylvania, United States
Pfizer Investigational Site
Wilkes-Barre, Pennsylvania, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Clarksburg, West Virginia, United States
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Liège, , Belgium
Pfizer Investigational Site
Kelowna, British Columbia, Canada
Pfizer Investigational Site
Kelowna, British Columbia, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Sydney, Nova Scotia, Canada
Pfizer Investigational Site
Kitchener, Ontario, Canada
Pfizer Investigational Site
Trois-Rivières, Quebec, Canada
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada
Pfizer Investigational Site
Montpellier, France, France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Toulouse, , France
Pfizer Investigational Site
Vogelsang, Gommern, Germany
Pfizer Investigational Site
Cologne, , Germany
Pfizer Investigational Site
Essen, , Germany
Pfizer Investigational Site
Würzburg, , Germany
Pfizer Investigational Site
Würzburg, , Germany
Pfizer Investigational Site
Budapest, , Hungary
Pfizer Investigational Site
Debrecen, , Hungary
Pfizer Investigational Site
Nyíregyháza, , Hungary
Pfizer Investigational Site
Mexicali, Baja California/Mexico, Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Morelia, Michoacán, Mexico
Pfizer Investigational Site
Culiacán, Sinaloa/Mexico, Mexico
Pfizer Investigational Site
Mexico City, , Mexico
Pfizer Investigational Site
Leiden, , Netherlands
Pfizer Investigational Site
Iași, Iaşi, Romania
Pfizer Investigational Site
Bucharest, Romania, Romania
Pfizer Investigational Site
Cluj-Napoca, Romania, Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Bucharest, , Romania
Pfizer Investigational Site
Belgrade, , Serbia
Pfizer Investigational Site
Niška Banja, , Serbia
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2051001
Identifier Type: -
Identifier Source: secondary_id
3206K1-2203
Identifier Type: -
Identifier Source: org_study_id
NCT01616706
Identifier Type: -
Identifier Source: nct_alias
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