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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00760864 |
The purpose of this study is to evaluate the safety and efficacy of TAK-715 in the treatment of rheumatoid arthritis signs and symptoms in patients with a partial response to methotrexate.
Condition | Intervention | Phase |
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Arthritis, Rheumatoid |
Drug: TAK-715 and methotrexate Drug: Methotrexate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis |
Enrollment: | 432 |
Study Start Date: | August 2004 |
Study Completion Date: | September 2005 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: TAK-715 and methotrexate
TAK-715 25 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.
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2: Experimental |
Drug: TAK-715 and methotrexate
TAK-715 50 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.
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3: Experimental |
Drug: TAK-715 and methotrexate
TAK-715 100 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.
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4: Placebo Comparator |
Drug: Methotrexate
TAK-715 placebo-matching, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Had moderate or severe liver disease at Screening, as defined by at least 1 of the following conditions:
Had taken, is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
A disease-modifying antirheumatic drug or a biologic agent other than methotrexate in the 8 weeks prior to Baseline, including:
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | 01-03-TL-715-005, 2004-002157-30 |
Study First Received: | September 24, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00760864 |
Health Authority: | United States: Food and Drug Administration |
Rheumatoid Arthritis Drug Therapy |
Folic Acid Signs and Symptoms Autoimmune Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |