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:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT02874092
Eligibility Criteria:
Inclusion Criteria
RA cohort
* Receiving MTX at stable doses of 10 to 25 mg weekly for at least 12 weeks
* Have a DAS28 of 3.2 or higher (The level of disease activity is considered to be low if the DAS28 is 3.2 or less) (Prevoo et al., 1995)
OA cohort
* Diagnosis of osteoarthritis made by physician.
Exclusion Criteria:
RA cohort
* History of sensitivity to study medications or any of their excipients
* Previous intolerance to MTX
* Current treatment with antiplatelet therapy
* Absolute indication for anti-platelet therapy
* Need for chronic oral anticoagulant therapy
* Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
* Renal failure (eGFR \<30 or requiring dialysis)
* A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding
* Prior stroke
* Active pathological bleeding
* History of intracranial haemorrhage
* Life expectancy \<12 months based on investigator's judgement
* Patients considered to be at risk of bradycardic events (e.g., known sick sinus syndrome or second or third degree atrioventricular \[AV)\] block) unless already treated with a permanent pacemaker
* Anemia (hematocrit \< 27%)
* Platelet count \< 100,000/ml
* Concomitant use of strong CYP 3A inhibitors or inducers
* History of thrombocytopenia or neutropenia
* Pregnant or nursing women, or females with a positive pregnancy test at screening
* Females of child bearing potential not using acceptable method of birth control prior to or during study
* Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)
OA cohort:
* History of sensitivity to study medications or any of their excipients
* Current treatment with antiplatelet therapy
* Absolute indication for anti-platelet therapy
* Need for chronic oral anticoagulant therapy
* Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
* Renal failure (eGFR \<30 or requiring dialysis)
* A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding
* Prior stroke
* Active pathological bleeding
* History of intracranial haemorrhage
* Life expectancy \<12 months based on investigator's judgement
* Anemia (hematocrit \< 27%)
* Platelet count \< 100,000/ml
* History of thrombocytopenia or neutropenia
* Pregnant or nursing women, or females with a positive pregnancy test at screening
* Females of child bearing potential not using acceptable method of birth control prior to or during study
* Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02874092
Study Brief:
Protocol Section:
NCT02874092