|
ISRCTN
|
ISRCTN54376151
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Methotrexate In Psoriatic Arthritis
|
|
Scientific title
|
|
|
Acronym
|
MIPA
|
|
Serial number at source
|
K0561
|
|
Study hypothesis
|
Psoriatic arthritis is a type of arthritis, which is often relatively mild and does not cause severe inflammation or long-term damage to joints. As a consequence many patients only need anti-inflammatory drugs and steroid injections into their joints. There is evidence that some patients with psoriatic arthritis have a more severe disease. They can become quite disabled and their joints damaged. As a consequence rheumatologists are keen to treat patients with more severe disease with disease modifying drugs, in particular a drug called methotrexate. This is the most effective drug of its class when used to treat rheumatoid arthritis. It also improves the skin in psoriasis. At present there is insufficient evidence that it works in psoriatic arthritis. The purpose of this study is to determine whether treatment with methotrexate is effective in psoriatic arthritis. It will determine if methotrexate reduces disease activity and improves function in patients whose disease is severe enough for their rheumatologist to consider using a disease modifying drug. The MIPA study will compare the effect of methotrexate against a placebo in patients with psoriatic arthritis. The trial will assess their function over six months.
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Psoriatic arthritis
|
|
Participants - inclusion criteria
|
Patients with psoriatic arthritis currently attending specialist rheumatology clinics and with active peripheral synovitis.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
30/04/2002
|
|
Anticipated end date
|
31/10/2008
|
|
Status of trial
|
Ongoing
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Patients will be randomised to methotrexate or placebo.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Arthritis Research Campaign (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Gabrielle
Kingsley
|
|
Address
|
Rheumatology Unit
GKT School of Medicine
5th Floor, Thomas Guy House
Guy's Campus
St Thomas Street
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 9RT
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7995 4394
|
|
Fax
|
+44 (0)20 7955 2472
|
|
Email
|
gabrielle.kingsley@kcl.ac.uk
|
|
Sponsor
|
Arthritis Research Campaign (ARC) (UK)
|
|
Address
|
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
|
|
City/town
|
Derbyshire
|
|
Zip/Postcode
|
S41 7TD
|
|
Country
|
United Kingdom
|
|
Email
|
info@arc.org.uk
|
|
Sponsor website:
|
http://www.arc.org.uk
|
|
Date applied
|
04/02/2002
|
|
Last edited
|
03/10/2007
|
|
Date ISRCTN assigned
|
04/02/2002
|
