Randomized, double-blind, placebo-controlled, dose-range study to assess the safety and efficacy of oral TAK-715 in the treatment of signs and symptoms of rheumatoid arthritis
- Conditions
- -M059M059
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
a) The patient is able to comply with the protocol and has signed the informed consent form
b) The subject is a man or woman 18 years of age or older, diagnosed with rheumatoid arthritis
c) Women who are able to conceive should not be pregnant or breastfeeding
d) The patient must have undergone a physical examination that in the opinion of the researcher, does not demonstrate clinically significant abnormalities
e) The patient must have laboratory tests whose results are normal or if abnormal, are not clinically significant
f) The patient must have a normal electrocardiogram or if abnormal, it should not be clinically significant
g) The patient should have a chest radiograph that shows no signs of active tuberculosis or clinically significant findings.
h) The patient should have a negative skin test of the purified protein derivative (PPD)
i) The patient must have been receiving methotrexate orally or parenterally for at least 6 months before and should receive a stable dose of methotrexate for at least 4 weeks before the baseline visit.
j) In the selection and baseline visits, the patient must have at least 6 inflamed joints and 9 painful joints
k) At the screening visit, the patient should have a CRP of at least 1.2 mg / dL or an ESR of at least 28 mm / hour.
1) If a patient is taking a systemic corticosteroid, the maintenance dose of prednisone or its equivalent should remain stable for at least 4 weeks, may not exceed 10 mg / day and the patient should continue with that stable dose throughout the study.
m) If a patient is taking an NSAID for the treatment of rheumatoid arthritis, the maintenance dose of NSAID should remain stable for at least 4 weeks before the baseline visit and the patient should continue with that stable dose throughout the study
a) The patient has been diagnosed with any type of arthritis at 16 years of age or earlier.
b) The patient has a clinically relevant history of disease.
c) The patient has a known history of human immunodeficiency virus (HIV) infection.
d) The patient has a known history of hepatitis B or C.
e) The patient has uncontrolled hypertension.
f) The patient has moderate or severe liver disease.
g) The patient has a high serum creatinin
h) The patient has a hemoglobin less than 9.0 mg / dL, a white blood cell count less than 3,000 / inn or a platelet count less than 100,000 / mm3
i) The patient has a functional status IV for rheumatoid arthritis
j) The patient has used an antirheumatic disease modifier drug (DMARD) or
a biological agent other than methotrexate in the previous 8 weeks
k) The patient has failed treatment due to lack of efficacy with any anti-TNF agent.
l) The patient has failed due to lack of efficacy with more than 2 DMARDs m) The patient has received any intra-articular, intramuscular or intravenous corticosteroid within the previous 4 weeks
n) The patient has received an alkylating agent.
o) The patient has a high risk of opportunistic infection
p) The patient has antecedents of, or a current inflammatory condition with signs and symptoms that could confuse the diagnosis of rheumatoid arthritis
q) The patient has been diagnosed with secondary, non-inflammatory arthritis.
r) The patient has a history of drug abuse within the past 2 years.
s) The patient has a BMI greater than 35
t) The patient has a previous history of cancer, other than basal cell carcinoma , which has not been in remission for at least 5 years before
u) The patient does not want or is not able to comply with the protocol
v) The patient can not understand written or spoken English or any other language in which a certified translation of the approved informed consent is available.
w) The patient has known hypersensitivity to TAK-715 or its components.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:20% improvement in the ACR (American College of Rheumatology) scale.<br>Measure:Primary efficacy of TAK-715 in combination with methotrexate.<br>Timepoints:Evaluation will be done in week 6.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:50% improvement (ACR50) and 70% (ACR70) on the ACR scale (American College of Rheumatology)<br>Measure:Efficiency during the 6 weeks, of the 3 dose levels of TAK-715 in combination with methotrexate<br>Timepoints:Evaluations will be made in weeks 4, 5 and 6<br>;<br>Outcome name:Clinical evaluation: of adverse events, physical examination, taking of vital signs and weight of the patient.<br>Laboratory tests: Serum chemical hematology panels, urinalysis, CRP, ESR.<br>12-lead ECG.<br>Measure:Safety of the treatment.<br>Timepoints:Evaluation of adverse events: Day 1, weeks 2, 4, 6 and 7.<br>Evaluation of vital signs: Day 1, weeks 2, 4, 6 and 7.<br>Weight evaluation and physical examination: Before starting the treatment and in week 6.<br>ECG: Before starting treatment.<br>Serum chemical hematology panels, urinalysis: Before treatment and weeks 2, 4, 6 and 7.<br>CRP, ESR: Before treatment and weeks 2, 4, and 6.<br>