Rheumatoid arthritis (RA) MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Code: TAK-783
Pharmaceutical Form: Tablet
Current Sponsor code: TAK-783
Concentration unit: % percent
Concentration type: range
Concentration number: 90-110
Pharmaceutical form of the placebo:
Sponsors
Takeda Global R&D (Europe) Ltd
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 and less than 3 years, 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 8 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. Subjects must have a normal chest X-ray within 3 months of the pre-treatment period. Subjects must have a negative (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who have hypersensitivity to TAK-783 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), or clinical laboratory and diagnostic screening tests as determined by the investigator. The subject has failed therapy due to lack of efficacy with more than 2 disease-modifying anti-rheumatic 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.) • Intra- or peri-articular joint injections are not allowed during the study. • Any investigational drugs within 30 days prior to randomization and throughout the trial. f) The subject has uncontrolled hypertension. g) The subject has moderate or severe liver disease, as defined by one or more of the following at the Screening Visit: i. Aspartate or alanine transaminase (AST or ALT) greater than 1.2 times ULN. ii. Total bilirubin greater than 1.2 times ULN (excluding subject’s diagnosed with Gilbert’s Disease). iii. Alkaline phosphatase greater than 1.5 times ULN. h) The subject has elevated serum creatinine level for age and gender at the Screening Visit. i) The subject has hemoglobin less than 9.0 mg/dL, white blood cell count of less than 3000/mm3 or a platelet count less than 100,000/mm3 at the Screening Visit. j) The subject has an ACR revised rheumatoid arthritis functional status of IV at the Screening Visit. k) The subject has used a disease-modifying antirheumatic drug (DMARD) or a biologic agent other than methotrexate (including sulfasalazine, tetracycline, leflunomide [AravaÒ] infliximab [RemicadeÒ], leflunomide [AravaÒ], etanercept [EnbrelÒ], adalimumab (HumiraÒ), or anakinra [KineretÒ]) in the 12 weeks prior to the Baseline Visit. l) The subject has used plaquenil in the 6 months prior to the Baseline Visit. m) The subject has ever received abatacept (OrenciaÒ) or rituximab (RituxanÒ). n) The subject has failed due to lack of efficacy with more than 2 DMARDs (other than methotrexate). o) The subject has received any intra-articular, intramuscular, or intravenous corticosteroids within 4 weeks prior to the Baseline Visit. p) The subject has had any previous use of cyclophosphamide, chlorambucil, or other alkylating agent. q) The subject is at high risk of an opportunistic infection because of a compromised immune system, in the investigator’s opinion, with the exception of subjects receiving chronic steroid treatment. r) The subject has a history of, or a current inflammatory condition with signs and symptoms that might confound the diagnosis of rheumatoid arthritis (eg, connective tissue disease, systemic lupus erythematosis, psoriasis, psoriatic arthritis, spondyloarthropathy). s) The subject has been diagnosed as having a secondary, non-inflammatory type of arthritis (eg, osteoarthritis [OA] or fibromyalgia) that, in the investigator’s opinion, is symptomatic enough to interfere with th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy by ACR20 response rates of TAK-783 in combination with methotrexate versus placebo plus methotrexate in the treatment of the signs and symptoms of rheumatoid arthritis over 12 weeks in subjects with a partial response to methotrexate. - To evaluate the safety of the combination of TAK-783 in combination with methotrexate versus placebo plus methotrexate over 16 weeks. ;Secondary Objective: - To evaluate the efficacy by ACR20 response rates of TAK-783 in combination with methotrexate versus placebo plus methotrexate in the treatment of the signs and symptoms of rheumatoid arthritis over 12 weeks in subjects with a partial response to methotrexate. - To evaluate the safety of TAK-783 in combination with methotrexate versus placebo plus methotrexate over 12 weeks. ;Primary end point(s): Composite ACR20 response rates at Week 12 | — |
Countries
Czech Republic, Hungary, Latvia
Outcome results
None listed