A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
- Conditions
- -M069M069
- Registration Number
- PER-047-08
- Lead Sponsor
- ARRAY BioPharma Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Have given written informed consent and expressed their willingness to comply with scheduled visits, treatment plans, laboratory tests and other study procedures;
• Man or woman> 18 years old;
• Have received a stable dose of methotrexate (> 10 mg <25 mg weekly) for> 6 weeks prior to selection and express their willingness to ´continue this regimen throughout the study;
• They have never received biological agents [Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Kineret® (anakinra), Orencia® (abatacept), Rituxan (rituximab)] for the treatment of RA and agree not to use them during the study;
• They have been diagnosed with AR before the Screening visit in accordance with the 1987 Revised Criteria of the American College of Rheumatology (ACR)
• The diagnosis of RA must have been present for at least 3 months.
• Current minimum level of activity of the disease characterized by:> 6 sensitive joints: Sensitive Joint Count (TJC) (count of 28 joints) AND> 6 swollen joints: Count of Joint Tumefactae (SJC) (count of 28 joints), And C-reactive protein (CRP)> 1.0 mg / dl (10 mg / l)
• Compliance with the 1991 Revised Criteria of the ACR for the State of Global Functioning in the RA, Classes I, II or III;
• They have completed a washout period of 4 weeks, unless indicated otherwise (calculated from the first dose of the study medication)
• Patients may continue their stable base treatment for RA (dosages must have been stable for at least 6 weeks before the first dose of study medication and unchanged during the 12 weeks of the Treatment Period, except that the patient discontinues it for documented improvement of the disease, with the approval of the Sponsor),
• They have received a stable dose of folate> 5 mg weekly) for> 6 weeks and show willingness to continue in this regimen throughout the study;
• Patients diagnosed with any other inflammatory or non-inflammatory arthritis (for example, spondyloarthropathies, fibromyalgia, psoriatic arthritis, gouty arthropathy demonstrated by crystals) that could interfere with evaluations of clinically evident disease activity or osteoarthrosis that could affect the evaluations later of effectiveness;
• History of renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac or neurological disease, severe, progressive and / or uncontrolled, or severe systemic involvement with rheumatoid arthritis, including rheumatoid vasculitis, Felty´s syndrome or pulmonary fibrosis within 6 months prior to the administration of the first dose of the study medication;
• History of associated significant heart disease: myocardial infarction in the 6 months prior to selection, instable angina, congestive heart failure (New York Heart Association (NYHA) Ciase III-IV), known arrhythmias of ventricular etiology, unexplained syncope or syncope / seizures related to arrhythmias
• History of serious or life-threatening chronic or recent infection in the 6 months prior to the administration of the first dose (defined as those requiring parenteral antibiotics or hospitalization);
• History of active tuberculosis or a history of tuberculosis without documented curative treatment and / or positive tuberculin reaction to PPD (Protected Protein Derivative) without known vaccination with the Bacillus Calmette-Guerin (BCG) vaccine. Patients with a history of BCG with a clearly defined scar are exempt from PPD test and chest x-ray.
• History of T-SPOT TB positive, when used or a comparable diagnostic test;
• History of significant trauma or major surgery in the 8 weeks prior to the administration of the first dose of the study medication;
• History of alcohol abuse with less than 12 months of sobriety or any drug abuse in the 3 years prior to the screening visit;
• History of cancer, in remission for <5 years except for patients with basal cell or squamous cell carcinoma or non-metastatic cervical carcinoma in situ adequately treated or resected.
• Any condition that could affect the absorption of oral medication (for example, gastrectomy, any malabsorption syndrome or clinically significant diabetic gastroenteropathy);
• Any clinically significant skin lesions as described in CTCAE Version 3.0
• Documented body temperature> 37´´C (98.6 ° F) in the baseline assessment;
• Infection with the human immunodeficiency virus (HIV) or hepatitis B or C;
• Any clinically significant active infection including herpetic lesions;
• Confirmed average QTc interval in triplicate of the Selection> 450 msec;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method