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Self monitoring of methotrexate by patients with arthritis

Self monitoring of treatment with methotrexate alone or in combination with anti-tumour necrosis factor alpha by patients with arthritis: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21613721
Enrollment
150
Registered
2011-06-29
Start date
2010-02-01
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid and psoriatic arthritis Musculoskeletal Diseases Rheumatoid arthritis

Interventions

1. Demorgaphics (age, gender, living status, ethnicity) and clinical data (date of diagnosis, methotrexate start date, number of previous disease modifying anti-rheumatic drugs) will be collected at b

Sponsors

Joint UCLH and UCL Biomedical Research Unit (United Kingdom)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All patients with a diagnosis of Rheumatoid or Psoriatic arthritis 2. Aged 18 years or over 3. Fluency in written and spoken English 4. Patients whose treatment is classified as stable defined as those who have had disease management with methotrexate for at least 6 months, plus a further 6 months if the patient is receiving a self-injected anti-TNF agent (Adaliumab or Etanercept)

Exclusion criteria

Exclusion criteria: 1. Identifiable psychosis or dementia 2. Significant co-morbidity (i.e. their predominant treatment is for another illness) 3. Those whose blood tests are being monitored by their GP

Design outcomes

Primary

MeasureTime frame
The self management role and responsibility subscale of the Medication Education Impact Questionnaire, measured at baseline and again after the 3rd and 6th blood tests.

Secondary

MeasureTime frame
1. Impact of Methotrexate assessed by Medication Impact Questionnaire at baseline and after 3rd and 6th blood test 2. Knowledge about Methotrexate assessed by Methotrexate in Rheumatoid Arthritis Knowledge at baseline and after 3rd and 6th blood test 3. Impact of arthritis assessed by Health Education Impact Questionnaire at baseline and after 3rd and 6th blood test 4. Mood, anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS) at baseline and after 3rd and 6th blood test 5. Beliefs about arthritis assessed by Illness Perceptions Questionnaire Revised at baseline and after 3rd and 6th blood test 6. Social support at baseline and after 3rd and 6th blood test 7. Generalised Self Efficacy at baseline and after 3rd and 6th blood test 8. Beliefs about Methotrexate assessed by Beliefs about Medication Questionnaire at baseline and after 3rd and 6th blood test 9. Healthcare utilisation assessed by Treatment Burden (1-item measure) at baseline and after 3rd and 6th blood test 10. Self-reported adherence to Methotrexate Medication Adherence Report Scale at baseline and after 3rd and 6th blood test 11. Functional disability assessed by Health Assessment Questionnaire-II at baseline and after 3rd and 6th blood test 12. Pain in last 2 weeks assessed by Pain Visual Analogue Scale (VAS) (0-10) at baseline and after 3rd and 6th blood test 13. Fatigue in last 2 weeks assessed by Fatigue VAS (0-10) at baseline and after 3rd and 6th blood test 14. Disease activity (RA & PsA) assessed by Disease Acitivity Score in Rheumatoid Arthirtis-28 & Psoriatic Arthritis Response Criteria at baseline and after 6th blood test

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026