Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT01132118
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Able to provide informed consent and comply with study visits
* Hemoglobin ≥ 10 g/dL (within last two months)
* WBC ≥ 4 K/uL (within last two months)
* Platelet count ≥ 150 ≤ 450 K/uL (within last two months)
* (GFR) Creatinine clearance ≥ 70 ml/min (MDRD) (within last two months)
* SGOT, SGPT ≤ 1.5 times upper limits of normal (within last two months)
* Normal eye exam within 12 months of study entry (copy of letter from subject's ophthalmologist or optometrist stating that the subject has no evidence of macular pathology)
* Diagnosis of rheumatoid arthritis
Exclusion Criteria:
* History of any neuromuscular disease including muscular dystrophy, metabolic myopathies, peripheral neuropathy, multiple sclerosis, and other myopathies or myositides
* History of diabetes or fasting plasma glucose of 126 mg/dl or greater
* History of any untoward reaction to antimalarials
* Uncontrolled hypertension (\>140/90)
* History of any ophthalmologic disease except for glaucoma or cataracts
* Planned elective surgery during the study period
* Digoxin therapy
* Treatment with corticosteroids (\> 5 mg) for any disorder
* History of psoriasis
* Any chronic disease that in the opinion of the investigator warrants exclusion (e.g. inflammatory bowel disease, malignancy other than basal cell carcinoma, chronic liver disease)
* History of chronic intestinal disorders (Crohn's disease, ulcerative colitis, celiac sprue, collagenous colitis, eosinophilic enteritis)
* Creatinine clearance ≤ 60 ml/min (MDRD) (within last two months)
* Hemoglobin ≤ 10 g/dL (within last two months)
* WBC ≤ 4 K/uL (within last two months)
* Platelet count ≤ 150 ≥ 450 K/uL (within last two months)
* SGOT, SGPT ≥ 1.5 times upper limits of normal (within last two months)
* Women who are pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01132118
Study Brief:
Protocol Section:
NCT01132118