Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Professor P Woo


Contact details

Department of Molecular Pathology
Centre for Paediatric and Adolescent Rheumatology
Windeyer Institute
46 Cleveland Street
United Kingdom
+44 (0)20 7436 0783

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Juvenile Idiopathic Arthritis (JIA)


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



Not Specified

Drug names


Primary outcome measure

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Screening phase (pre-randomisation):
a. Definite diagnosis of JIA with onset before the 16th birthday (Cimaz & Fink 1996 - href=¿
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


Age group




Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Molecular Pathology
United Kingdom

Sponsor information


Arthritis Research Campaign (ARC) (UK)

Sponsor details

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

Sponsor type




Funder type


Funder name

Arthritis Research Campaign (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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
2. 2010 results in
3. 2010 results in

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes