Hand OA AND Methotrexate Use | NCT01927484 | Trialant

Hand OA AND Methotrexate Use | NCT01927484 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
methotrexate	Experimental	25mg oral methotrexate tablets	Drug: 25 mg/week oral methotrexate tablets
placebo	Placebo Comparator	25 mg/week placebo tablets	Drug: 25mg/week oral placebo tablets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain reduction	The primary outcome will be pain reduction at 28 weeks compared to baseline using a Visual Analogue Pain Scale (VAS) 0-100 mm. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline.	28 weeks

Secondary Outcomes

Measure	Description	Time Frame
physical function improvement Functional assessment	Improvements in physical functioning McMaster Universities Osteoarthritis Index (WOMAC) subscores for pain, stiffness and function , the patient global assessment of the severity of knee OA measured on a 0-100 mm VAS. The physician-reported disease activity VAS was also recorded. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline.

Other Outcomes

Measure	Description	Time Frame
safety and tolerability	Safety and tolerability to treatment will be assessed at each visit. Safety will be assessed by identifying adverse events using open-ended questions and a checklist including common oral methotrexate side effects, physical examination and by laboratory assessment including complete blood picture and liver enzymes. Adverse events will be collected at each visit and up to 28 weeks.

Condition Browse Module

Intervention Browse Module