Methotrexate In Psoriatic Arthritis
| ISRCTN | ISRCTN54376151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54376151 |
| Protocol serial number | K0561 |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Funder | Arthritis Research Campaign (UK) |
- Submission date
- 04/02/2002
- Registration date
- 04/02/2002
- Last edited
- 23/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gabrielle Kingsley
Scientific
Scientific
Rheumatology Unit
GKT School of Medicine
5th Floor, Thomas Guy House
Guy's Campus
St Thomas Street
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7995 4394 |
|---|---|
| gabrielle.kingsley@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | MIPA |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Psoriatic arthritis |
| Intervention | Patients will be randomised to methotrexate or placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with psoriatic arthritis currently attending specialist rheumatology clinics and with active peripheral synovitis. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/04/2002 |
| Date of final enrolment | 31/10/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Rheumatology Unit
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No | |
| Other publications | current concepts and new developments | 01/10/2003 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
