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| Multicentre randomised actively controlled trial of parenteral methotrexate in medium versus low doses in Juvenile Idiopathic Arthritis (JIA) |
| Source of record | UK Trials |
| ISRCTN | ISRCTN59862338 |
| Date ISRCTN assigned | 06/01/2003 |
| Local reference number(s) | W0580 |
| Public title | Multicentre randomised actively controlled trial of parenteral methotrexate in medium versus low doses in Juvenile Idiopathic Arthritis (JIA) |
| Scientific title | |
| Acronym | PRINTO |
| Disease/condition/study domain | Juvenile Idiopathic Arthritis (JIA) |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Screening phase (pre-randomisation): a. Definite diagnosis of JIA with onset before the 16th birthday (Cimaz & Fink 1996 - href=¿http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=f1000&cmd=Retrieve&db=PubMed&list_uids=8882046) b. Patients starting methotrexate for the first time (oral, subcutaneous [SC] or intramuscular [IM] 8-12.5 mg/m^2 once a week) c. At least two other abnormal variables of any of the six core set parameters. The physician and the parents' ratings must both be at least one on a 10 cm Visual Analogue Scale (VAS), and the Childhood Health Assessment Questionnaire (CHAQ) score greater than zero 2. Trial phase (post-randomisation): a. Only patients who fail to respond to at least four but no more than six months of treatment with a standard dose of methotrexate (oral, SC or IM 8-12.5 mg/m^2 once a week) according to the definition of improvement will be randomised to receive either medium dose parenteral methotrexate (SC or IM 15 mg/m^2 once a week, max dose 20 mg a week) in the randomised phase of the trial b. Patients must be on a stable dose of no more than one Non-Steroidal Anti-Inflammatory Drugs (NSAID) for at least one month before the randomised period, and during the trial c. Low dose steroids (0.2 mg/kg/day [max 10 mg/day]), if administered, will be maintained below 0.2 mg/kg/day (max 10 mg/day) one month before enrolment in the randomisation phase, and throughout the trial d. Females of child bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must agree to use adequate contraception (i.e. oral contraceptive, diaphragm with spermicidal cream, or Intra-Uterine Device [IUD]), throughout study participation, and must have no intention of conceiving a child during the course of the study. e. Ability of the patients and/or parents to communicate meaningfully with the investigational staff, and competence to give written informed consent and/or assent, and ability to comply with the entire study procedures is essential f. Duly executed, written, informed consent from patients (if 18 years of age or older) or parents or other legal guardian or representative (if less than 18 years of age), and assent obtained from the patient (aged 12-18 years when appropriate) |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Anticipated start date | 01/01/2003 |
| Anticipated end date | 31/12/2007 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | All patients started on standard methotrexate therapy, after six months non-responding patients randomised to medium (max 20 mg/week) or high dose methotrexate (max 40 mg/week) |
| 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 |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House St Mary's Court St Mary's Gate Chesterfield Derbyshire United Kingdom S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Professor P Woo |
| Contact details | Department of Molecular Pathology Centre for Paediatric and Adolescent Rheumatology Windeyer Institute UCLMS 46 Cleveland Street London United Kingdom W1T 4JF |
| Contact telephone | +44 (0)20 7436 0783 |
| Contact fax | +44 (0)20 7679 9652 |
| Contact email | patricia.woo@ucl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN59862338 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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