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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002157-30-FI

Enrollment

400

Registered

2004-10-22

Start date

2004-12-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

Product Code: TAK-715 Pharmaceutical Form: Tablet Current Sponsor code: TAK-715 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the place

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men and women, who are capable of understanding and willing to sign the informed consent, are 18 years or older, with a diagnosis of rheumatoid arthritis for at least 6 months with partial response to methotrexate are to be included in this study. Subjects must have active rheumatoid arthritis using American College of Rheumatology (ACR) criteria (defined as =6 swollen joints and =9 tender joints, and a CRP =1.2 mg/dL or ESR =28 mm/hr) despite methotrexate therapy. All subjects must have been treated with methotrexate for at least 6 months and have been on a stable dose for at least 4 weeks prior to the Baseline Visit. Subjects on non-steroidal anti-inflammatory drugs (NSAIDs) must remain on a stable dose of their NSAIDs (throughout the study) and subjects on prednisone (or its equivalent) must remain on a stable maintenance dose (throughout the study) not to exceed 10 mg/day. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects who have hypersensitivity to TAK-715 or its constituents, with a significant history of uncontrolled hypertension, secondary, non-inflammatory type of arthritis, severe liver disease, or any significant results from physical exams, electrocardiograms (ECGs), chest x-ray, purified protein derivative (PPD) skin test for tuberculosis, or clinical laboratory and diagnostic screening tests as determined by the investigator. The subject has failed therapy due to lack of efficacy with any anti-TNF agent or 2 or more disease-modifying antirheumatic drugs (DMARDs) other than methotrexate. Excluded medication are: • All DMARDs and biologics other than methotrexate used to treat rheumatoid arthritis (including tetracycline when used as a DMARD). • Tetracyclines cannot be used for any reason during the study. • All systemic (non-DMARD) immunosuppressants with the exception of prednisone or its equivalent. • Controlled-release oxycodone (OxyContin?) and other non-NSAID long-acting analgesics. • Aspirin and aspirin-containing combination products used for analgesia. (Aspirin =325 mg/day for cardiac prophylaxis is permitted.) • CYP3A4 inhibitors, which include: grapefruit juice, itraconazole, ketoconazole, macrolide antibiotics (not azithromycin) and nefazodone. • Intra- or peri-articular joint injections are not allowed during the study. • Any investigational drugs within 30 days prior to enrollment and throughout the trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy by ACR20 response rates of 3 dose levels of TAK-715 in combination with methotrexate versus placebo plus methotrexate in the treatment of the signs and symptoms of rheumatoid arthritis at the end of 6 weeks in subjects with a partial response to methotrexate. To evaluate the safety of the combination of TAK-715 at each of the 3 dose levels in combination with methotrexate versus placebo plus methotrexate over 6 weeks.;Secondary Objective: To evaluate the efficacy by ACR50 and ACR70 response rates of 3 dose levels of TAK-715 in combination with methotrexate versus placebo plus methotrexate in the treatment of the signs and symptoms of rheumatoid arthritis over 6 weeks. ;Primary end point(s): The primary safety endpoints will include the following parameters: • Adverse events • Hematology, chemistry and urinalysis laboratory test results • Vital signs • Physical examination findings • Weight • ECG findings The primary efficacy endpoint for this study is the composite ACR20 response rates at Week 6 for the 3 TAK-715 groups versus the response rate for the placebo group.	—

Measure

Time frame

Main Objective: To evaluate the efficacy by ACR20 response rates of 3 dose levels of TAK-715 in combination with methotrexate versus placebo plus methotrexate in the treatment of the signs and symptoms of rheumatoid arthritis at the end of 6 weeks in subjects with a partial response to methotrexate. To evaluate the safety of the combination of TAK-715 at each of the 3 dose levels in combination with methotrexate versus placebo plus methotrexate over 6 weeks.;Secondary Objective: To evaluate the efficacy by ACR50 and ACR70 response rates of 3 dose levels of TAK-715 in combination with methotrexate versus placebo plus methotrexate in the treatment of the signs and symptoms of rheumatoid arthritis over 6 weeks. ;Primary end point(s): The primary safety endpoints will include the following parameters: • Adverse events • Hematology, chemistry and urinalysis laboratory test results • Vital signs • Physical examination findings • Weight • ECG findings The primary efficacy endpoint for this study is the composite ACR20 response rates at Week 6 for the 3 TAK-715 groups versus the response rate for the placebo group.

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Countries

Denmark, Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026