Contact information
Type
Scientific
Primary contact
Professor P Woo
ORCID ID
Contact details
Department of Molecular Pathology
Centre for Paediatric and Adolescent Rheumatology
Windeyer Institute
UCLMS
46 Cleveland Street
London
W1T 4JF
United Kingdom
+44 (0)20 7436 0783
patricia.woo@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
W0580
Study information
Scientific title
Acronym
PRINTO
Study hypothesis
Not provided at time of registration
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
Condition
Juvenile Idiopathic Arthritis (JIA)
Intervention
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)
Intervention type
Drug
Phase
Not Specified
Drug names
Methotrexate
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2003
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Molecular Pathology
London
W1T 4JF
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
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
Basic results (scientific)
Publication list
1. 2010 safety and efficacy results in http://www.ncbi.nlm.nih.gov/pubmed/20237125
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20525842
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20822542
Publication citations
-
Safety and efficacy results
Ruperto N, Lovell DJ, Cuttica R, Woo P, Meiorin S, Wouters C, Silverman ED, Balogh Z, Henrickson M, Davidson J, Foeldvari I, Imundo L, Simonini G, Oppermann J, Xu S, Shen YK, Visvanathan S, Fasanmade A, Mendelsohn A, Martini A, Giannini EH, , , Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension., Ann. Rheum. Dis., 2010, 69, 4, 718-722, doi: 10.1136/ard.2009.100354.
-
Results
Vilca I, Munitis PG, Pistorio A, Ravelli A, Buoncompagni A, Bica B, Campos L, Häfner R, Hofer M, Ozen S, Huemer C, Bae SC, Sztajnbok F, Arguedas O, Foeldvari I, Huppertz HI, Gamir ML, Magnusson B, Dressler F, Uziel Y, van Rossum MA, Hollingworth P, Cawkwell G, Martini A, Ruperto N, , Predictors of poor response to methotrexate in polyarticular-course juvenile idiopathic arthritis: analysis of the PRINTO methotrexate trial., Ann. Rheum. Dis., 2010, 69, 8, 1479-1483, doi: 10.1136/ard.2009.120840.
-
Results
Visvanathan S, Wagner C, Marini JC, Lovell DJ, Martini A, Petty R, Cuttica R, Woo P, Espada G, Gattorno M, Apaz MT, Baildam E, Fasth A, Gerloni V, Lahdenne P, Quartier P, Saurenmann R, Travers S, Mendelsohn A, Xu S, Giannini EH, Ruperto N, , , The effect of infliximab plus methotrexate on the modulation of inflammatory disease markers in juvenile idiopathic arthritis: analyses from a randomized, placebo-controlled trial., Pediatr Rheumatol Online J, 2010, 8, 24, doi: 10.1186/1546-0096-8-24.