Condition category
Musculoskeletal Diseases
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
09/03/2015
Prospective/Retrospective
Prospectively 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

Dr N Wulffraat

ORCID ID

Contact details

University Medical Center Utrecht (UMCU)
Department of Pediatric Immunology and Rheumatology
KC 03.063
P.O. Box 85090
Utrecht
3508 AB
Netherlands
+31 (0)88 75 5 4003
N.Wulffraat@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prevention of methotrexate-induced psychological intolerance in children with juvenile idiopathic arthritis

Acronym

Study hypothesis

The aims of this study are:
1. To explore the incidence of Methotrexate (MTX) related gastro-intestinal in a large cohort of Juvenile Idiopathic Arthritis (JIA) patients
2. To investigate the effect of psychological behavioural therapy or switch to parenteral MTX dosing to ameliorate these side effects

In a pilot study such a behavioural therapy was successful in 11 of 20 JIA patients. These patients could therefore continue the MTX, and did not need to switch to alternative medication (often more immunosuppressive, toxic and very expensive).

Ethics approval

Medical Ethics Committee of the University Medical Center Utrecht and other participating centers for local feasibility, 21/06/2007, ref: 07/053

Study design

Randomised parallel-group multicentre trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Juvenile Idiopathic arthritis (JIA)

Intervention

Patients will be randomised for:
1. Behavioral therapy plus continuation of oral MTX (intervention)
2. Switch to parenteral MTX (control)
3. Continuation of standard of care plus anti-emetic drugs (control)

Intervention type

Drug

Phase

Not Applicable

Drug names

Methotrexate

Primary outcome measures

1. The number of patients continuing MTX
2. Number of patients reporting gastrointestinal side effects
3. JIA disease activity parameters

Measured: 0, 3, 6 and 12 months.

Secondary outcome measures

1. JIA disease activity parameters (Pediatric Rheumatology InterNational Trials Organisation [PRINTO] core set criteria)
2. Metabolomics and folate/homocysteine/adenosine metabolites
3. Inflammation parameters (Erythrocyte Sedimentation Rate [ESR], C-Reactive Protein [CRP], cytokine profiles, T regulatory [T-regs] cells, Measles, Mumps, Rubella [MMR] antibodies)
4. MTX related cytopenias

Measured: 0, 3, 6 and 12 months.

Overall trial start date

01/03/2007

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis: all subtypes JIA according to International League of Associations for Rheumatology (ILAR) classification
2. Ages 4 to 17 years
3. MTX oral (dosing 10 to 20 mg/m^2/week)
4. Other medication: Non-Steroidal Anti-Inflammatory Drug (NSAID), biologicals (etanercept, infliximab, anakinra) allowed

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. MTX parenteral
2. Other diagnosis
3. Steroid usage (more than 0.2 mg/kg/day)
4. Other MTX related side effects

Recruitment start date

01/03/2007

Recruitment end date

01/03/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

Department of Pediatrics
P.O. Box 85090
Utrecht
3508 AB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Industry

Funder name

Pharmachemie (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medac (The Netherlands)

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25745368

Publication citations

Additional files

Editorial Notes