A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis ESCAPE
- Conditions
- -M05M05
- Registration Number
- PER-065-08
- Lead Sponsor
- AstraZeneca AB,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Provide informed consent (including consent for the PK subgroup, as applicable).
• Be male or female over 18 years of age. Note: Women with pregnancy potential can be included only if highly effective contraceptive methods are used (see Section 3.3.4 and Appendix K) and if patients are fully aware of the information regarding the possibility of reproductive toxicity according to it is detailed in the informed consent form. Men who participate in the study should agree to abstain from having sex for procreative purposes during the study and for 12 weeks after the last dose of study medication.
• Diagnosis of RA after 16 years of age according to the revised criteria (1987) American Collegue of Rheumatology.
• Have active RA defined as follows: -> 4 swollen joints and> 6 tender / painful joints and: ESR> 28 mm / h or CRP> 10 mg / L.
• Have at least one of the following items: - Documented background of positive rheumatoid factor - Current presence of rheumatoid factor - Basal radiographic erosion - Presence of anti-citrullinated cyclic peptide antibodies (anti-CCP) in serum.
• Oral, subcutaneous or intramuscular methotrexate for a minimum of 6 months prior to randomization. The dose and means of administration of methotrexate should have been stable between 5 mg and 25 mg per week for a minimum of 6 weeks prior to randomization.
• Pregnant or lactating women (restrictions and procedures related to managing the risk of pregnancy / conception for men and women are set out in Sections 3.3.4 and 9.4).
• Any systemic inflammatory affection besides RA that may interfere with the interpretation of the outcome data (among other examples we can mention polymyalgia rheumatica, gigantocellular arteritis [including temporal], reactive arthritis).
• Current conditions with chronic pain, including fibromyalgia syndromes and chronic fatigue.
• Functional Class IV of the American College of Rheumatology or in a wheelchair / confined to the bed.
• Patients unable to comply with locally approved product information for etanercept. Note: any patient selected to receive etanercept will be confirmed as negative for LTBI prior to the start of treatment. In the event that the patient had a negative TB test in the month prior to Visit 1, the result of that analysis will prevail and the analysis should not be repeated. Patients who obtain positive results in the analysis should not continue, see Section 3.3.5.1).
• Patients who previously did not respond to treatment with more than 1 biological agent.
• Patients who, in the investigator´s opinion, have active TB as defined by clinical history and / or chest x-ray.
• Patients who do not meet or are unlikely to comply with restrictions regarding the use of prior and concomitant medications as set forth in Section 3.7.
• Clinical or biochemical evidence of active infections with hepatitis B or hepatitis C (carriers may be included, ie those who have positive serology but have no evidence of active disease).
• The values of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin> 2 x upper limit to normal (ULN) in Visit 1.
• History of excessive alcohol consumption or chronic illness produced by it.
• Patients who, at the investigator´s discretion, have a higher risk of developing ventricular arrhythmias
• Chronic or acute kidney disease-patients may be included if the plasma / serum creatinine is within the normal range or, if abnormal, the calculated GFR (using the original Cockroft-Gault formula) or measured should be> 50 mL / min (see Appendix G).
• History of cancer or neoplastic pathology, except squamous or basal cell carcinoma successfully treated with> 5 years old.
• Any other clinically significant disorder or disease, which, in the investigator´s judgment, (by its nature or insufficiently controlled) may pose a risk to the patient due to participation in the study, or may influence the results of the study. study, or the patient´s ability to participate in the study, including chronic liver disease and the important history of recurrent infections.
• Be part of the planning and conduct of the study (applies to both AstraZeneca staff and the staff of the study center).
• Previous enrollment in the present study.
• Recent participation in any clinical study involving any compound under investigation within 3 months prior to the randomization or 5 half lives of the product under investigation (the most extensive period). Patients who participate in non-drug methodology studies (whether invasive or not) can be included immediately, at the investigator´s discretion.
• Patients who, in the opinion of the researcher, should not participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The patient has an ACR20 response if all the following items are produced:<br>• Improvement of> 20% in the count of inflamed joints (28 joints)<br>• Improvement of> 20% in the count of sensitive joints (28 joints)<br>• Improvement of> 20% in, at least, 3 of the following 5 evaluations: - Evaluation of the patients pain - Overall evaluation of the patient - Overall assessment of the physician on the activity of the disease - The patients assessment of physical function , as measured by the HAQ - CRP.<br>Measure:Proportion of patients achieving an ACR20 response in Week 12<br>Timepoints:Week 12<br>
- Secondary Outcome Measures
Name Time Method