Safety and Efficacy of TAK-715 in Subjects With Rheumatoid Arthritis

NCT00760864 | Completed Phase 2

• 3 other identifiers: 01-03-TL-715-0052004-002157-30U1111-1114-2984
• Study Type: interventional
• Target: 432
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of TAK-715, twice daily (BID), in the treatment of rheumatoid arthritis signs and symptoms in patients with a partial response to methotrexate.

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Composite ACR 20% improvement response rate from baseline with 3 of the following: pain assessment; disease activity; physical function; C-reactive protein and erythrocyte sedimentation rate.

  Week 6

Secondary Outcomes (12)

• Composite ACR 50% improvement response rate from baseline with 3 of the following: swollen-tender joint counts; pain assessment; disease activity; physical function; C-reactive protein and erythrocyte sedimentation rate.

  Week 6.

• Composite ACR 70% improvement response rate from baseline with 3 of the following: swollen-tender joint counts; pain assessment; disease activity; physical function; C-reactive protein and erythrocyte sedimentation rate.

  Week 6.

• Change from baseline in swollen and tender joint counts.

  Week 6

• Change from baseline in patient's assessment of pain.

  Week 6

• Change from baseline in patient's global assessment of disease activity.

  Week 6

Study Arms (4)

TAK-715 25 mg BID

EXPERIMENTAL

Drug: TAK-715 and methotrexate

TAK-715 50 mg BID

EXPERIMENTAL

Drug: TAK-715 and methotrexate

TAK-715 100 mg BID

EXPERIMENTAL

Drug: TAK-715 and methotrexate

Methotrexate

ACTIVE COMPARATOR

Drug: Methotrexate

Interventions

TAK-715 and methotrexate DRUG

TAK-715 25 mg, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks.

TAK-715 25 mg BID

Methotrexate DRUG

TAK-715 placebo-matching, tablets, orally, twice daily and methotrexate stable dose for up to 6 weeks

Methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had a diagnosis of rheumatoid arthritis using American College of Rheumatology criteria of at least 6 months duration.
• A female subject of childbearing potential who is sexually active must agree to use adequate contraception, and must be neither pregnant nor lactating from Screening throughout the duration of the study.
• Had a physical examination at Screening that revealed no clinically significant abnormalities (other than rheumatoid arthritis) in the investigator's opinion.
• Had clinical laboratory test results at Screening that were normal or, if abnormal, were not clinically significant in the investigator's opinion.
• Had a 12-lead electrocardiogram at Screening that was normal or, if abnormal, was not clinically significant in the investigator's opinion.
• Had a chest x-ray within 6 months prior to or during the Pretreatment Period that, in the investigator's opinion, showed no signs of active tuberculosis and was free of clinically significant findings.
• Had a negative purified protein derivative skin test for tuberculosis (less than or equal to 5 mm in duration) during the Screening Period.
• Had been receiving oral or parenteral methotrexate for at least 6 months prior to Baseline and must have been on a stable dose (12.5 to 25 mg per week, inclusive) of methotrexate for at least 4 weeks prior to Baseline. The subject must have been on a dose of folic acid at greater than or equal to 1 mg/day.
• Had at least 6 swollen and 9 tender joints using the 66/68 joint count scale at Screening and Baseline.
• At Screening, the subject must have had a C-reactive protein of at least 1.2 mg/dL or an erythrocyte sedimentation rate of at least 28 mm/hr.
• For individuals who were taking a systemic corticosteroid, the maintenance dose of prednisone, or its equivalent, could not exceed 10 mg/day and must have been stable for at least 4 weeks prior to Baseline and must have remained at that stable dose throughout the study.
• For individuals who were taking a nonsteroidal anti-inflammatory drug for the treatment of rheumatoid arthritis, the maintenance dose of the nonsteroidal anti-inflammatory drug must have been stable for at least 4 weeks prior to Baseline and must have remained at that stable dose throughout the study.

You may not qualify if:

• Had been diagnosed with any type of arthritis at age 16 or younger.
• Had a history of a clinically significant illness, medical condition, or laboratory abnormality within 3 months prior to Baseline that, in the investigator's opinion, would preclude the subject's participation in the study.
• Had a known history of human immunodeficiency virus infection.
• Had a known history of hepatitis B or C.
• Had uncontrolled hypertension.
• Had moderate or severe liver disease at Screening, as defined by at least 1 of the following conditions:
• Aspartate transaminase or alanine transaminase greater than 1.2 times the upper limit of normal.
• Total bilirubin greater than 1.2 times upper limit of normal (excluding subjects diagnosed with Gilbert's disease).
• Alkaline phosphatase greater than 1.5 times upper limit of normal.
• Had elevated serum creatinine level for age and gender at Screening.
• Had hemoglobin less than 9.0 g/dL, white blood cell count of less than 3000/mm3, or a platelet count less than 100,000/mm3 at Screening.
• Had an American College of Rheumatology revised rheumatoid arthritis functional status of IV at Screening.
• 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:
• Plaquenil.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

N-(4-(2-ethyl-4-(3-methylphenyl)-1,3-thiazol-5-yl)-2-pyridyl)benzamide; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• VP Biological Sciences

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 26, 2008
• Study Start: August 1, 2004
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: June 11, 2010

Record last verified: 2010-06