Multicentre randomised actively controlled trial of parenteral methotrexate in medium versus low doses in Juvenile Idiopathic Arthritis (JIA)

ISRCTN ISRCTN59862338
DOI https://doi.org/10.1186/ISRCTN59862338
Secondary identifying numbers W0580
Submission date
06/01/2003
Registration date
06/01/2003
Last edited
03/11/2011
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

Professor P Woo
Scientific

Department of Molecular Pathology
Centre for Paediatric and Adolescent Rheumatology
Windeyer Institute
UCLMS
46 Cleveland Street
London
W1T 4JF
United Kingdom

Phone +44 (0)20 7436 0783
Email patricia.woo@ucl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymPRINTO
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedJuvenile Idiopathic Arthritis (JIA)
InterventionAll 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)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Methotrexate
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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)
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2003
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Molecular Pathology
London
W1T 4JF
United Kingdom

Sponsor information

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom

Email info@arc.org.uk
Website http://www.arc.org.uk
ROR logo "ROR" https://ror.org/02jkpm469

Funders

Funder type

Charity

Arthritis Research Campaign (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article safety and efficacy results 01/04/2010 Yes No
Results article results 01/08/2010 Yes No
Results article results 07/09/2010 Yes No