Condition category
Musculoskeletal Diseases
Date applied
06/01/2003
Date assigned
06/01/2003
Last edited
03/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.arc.org.uk

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

Results - basic reporting

Publication summary

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

  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