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Biomarker Profiling of Pain in Juvenile Idiopathic Arthritis

Biomarker Profiling of Pain in Juvenile Idiopathic Arthritis - BioProPain in JIA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42093
Enrollment
80
Registered
2015-05-06
Start date
2016-02-18
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile idiopathic arthritis juvenile rheumatoid arthritis

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Age between 6 to 17 years - Ability to speak and understand Dutch - having been diagnosed with active JIA by their treating physician as defined by the ILAR-classification - having the most severe arthritis in either face, hand, knee or foot

Exclusion criteria

Exclusion criteria: - monoarthritis of the hip - serious injury to the body regions to be tested - Health problems such as Cystic Fibrosis, cancer, inflammatory bowel disease, drug or alcohol abuse; severe psychiatric disorder or dysfunction (e.g., major depression or generalized anxiety disorder requiring medical treatment) - Inability to understand the instructions

Design outcomes

Primary

MeasureTime frame
The main endpoint is the difference in pain rating between baseline, i.e. time of diagnosis, (t0) and at 3 (t1), 6 (t2) and 12 months (t3) after diagnosis, dichotomized in clinical relevant change of VAS-score, defined by a change in VAS score of either >= 20 mm or >= 30%.

Secondary

MeasureTime frame
Secondary endpoints are: 1. monocyte/macrophage GRK2 expression 2. LPS-induced monocyte p38 activation 3. cytokine profiles (ratio between pro- and anti-inflammatory cytokine responses) 4. QST profile 5. pain favouring cognition 6. medication (subgroups of medication, NSAID's, MTX, TNF-a blocking biologicals, non-TNF-a blocking biologicals), as a proxy of severity and duration of active JIA

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)