Condition category
Musculoskeletal Diseases
Date applied
04/02/2002
Date assigned
04/02/2002
Last edited
23/02/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gabrielle Kingsley

ORCID ID

Contact details

Rheumatology Unit
GKT School of Medicine
5th Floor
Thomas Guy House
Guy's Campus
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7995 4394
gabrielle.kingsley@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

K0561

Study information

Scientific title

Acronym

MIPA

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Psoriatic arthritis

Intervention

Patients will be randomised to methotrexate or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Methotrexate

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/04/2002

Overall trial end date

31/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with psoriatic arthritis currently attending specialist rheumatology clinics and with active peripheral synovitis.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/04/2002

Recruitment end date

31/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rheumatology Unit
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2003 current concepts and new developments in http://www.ncbi.nlm.nih.gov/pubmed/12810935
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22344575

Publication citations

  1. Current concepts and new developments

    Pipitone N, Kingsley GH, Manzo A, Scott DL, Pitzalis C, Current concepts and new developments in the treatment of psoriatic arthritis., Rheumatology (Oxford), 2003, 42, 10, 1138-1148, doi: 10.1093/rheumatology/keg363.

  2. Results

    Kingsley GH, Kowalczyk A, Taylor H, Ibrahim F, Packham JC, McHugh NJ, Mulherin DM, Kitas GD, Chakravarty K, Tom BD, O'Keeffe AG, Maddison PJ, Scott DL, A randomized placebo-controlled trial of methotrexate in psoriatic arthritis., Rheumatology (Oxford), 2012, 51, 8, 1368-1377, doi: 10.1093/rheumatology/kes001.

Additional files

Editorial Notes