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Methotrexate in Older Adults With Elevated Inflammation
NCT02079948Phase 2
Key facts
- Status
- Withdrawn
- Start
- Feb 2014
- Primary completion
- Sep 2014
- Sponsor
- University of Florida
- Modality
- Orthosteric Ligands
- Drugs
- methotrexate
- Conditions
- inflammation
01
Overview
Phase 2, randomised, double-blind trial in inflammation comparing Methotrexate + Folic Acid with Placebo + Folic Acid (2 arms). Primary endpoint: Markers of Systemic Inflammation at 6 months. Planned start Feb 2014; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Methotrexate + Folic Acid
Methotrexate up to 15 mg/week + Folic acid 1 mg/day for 6 days/week
Placebo + Folic Acid
Placebo matching methotrexate + Folic acid 1 mg/day for 6 days/week
03
Who it enrols
Older adults (>= 65 years) with elevated IL-6 levels, mild-to-moderate physical impairment, and low physical activity, excluding those with significant cardiovascular, lung, liver, or infectious diseases, or those taking interacting medications.
04
Endpoints
Primary
Markers of Systemic Inflammation
Secondary
Physical Function
Cognitive Performance
Pain Symptoms
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