Table 1 Summary of key CLUSTER studies
BCRD | BSPAR-Et | CAPS | CHARMS | |
|---|---|---|---|---|
Study type | Prospective observational | Prospective observational | Prospective longitudinal | Prospective/retrospective observational |
Aim of study | To capture information on use, effectiveness, and safety of biologic DMARDs other than etanercept | To evaluate the effectiveness and safety of etanercept treatment in JIA | To identify environmental, clinical and genetic predictors of short- and long-term outcomes in JIA | To understand why some children with JIA respond well to treatments and others do not |
Study dates | 2010—ongoing | 2004—ongoing | 2001—ongoing | 2006—ongoing |
Funders | Versus Arthritis | British Society of Rheumatology, Pfizer | Versus Arthritis | Sport Aiding Medical Research for Kids (SPARKS); MRC, Great Ormond Street Children’s Charity (GOSHCC) and NIHR-GOSH Biomedical Research Centre |
Recruiting locations | UK (43 sites) | UK (41 sites) | UK (7 sites) | England (7 sites), Utrecht, Prague |
Inclusion criteria | - fulfil ILAR classification criteria for JIA - starting either a non-etanercept biologic drug or MTX or have started this therapy within the past 6 months - no past exposure to biologic DMARDs (MTX comparison arm) - upper age limit of 17 | - fulfil ILAR classification criteria for JIA - starting either etanercept or MTX or have started this therapy within the past 6 months - no past exposure to biologic DMARDs (MTX comparison arm) | - aged 16 or below - diagnosed for the first time with inflammatory arthritis affecting one or more joints that have been persistent for more than 2 weeks | - fulfil ILAR classification criteria for JIA - about to start either MTX or TNFi (prospective arm) or already receiving MTX/TNFi for at least 6 months (retrospective arm) |
N of participants | ~ 1500 | ~ 2000 | ~ 1800 | ~ 1700 |
Baseline data collection | At the start of MTX or non-etanercept biologic treatment | At the start of MTX/etanercept treatment | At the point of JIA diagnosis | At the start of MTX/TNFi treatment |
Baseline data items | - demographics - clinical data - current and previous JIA medication | - demographics - clinical data - current and previous JIA medication | - demographics - family history of arthritis/autoimmune conditions - socio-economic information - clinical data - results of imaging studies - medication history | - demographics - clinical data - laboratory - medication history |
Follow-up data collection | 6 and 12 months following registration, then annually until at least year 5 | 6 and 12 months following registration, then annually until at least year 5 | 6 and 12 months from the first visit to paediatric rheumatology, then annually to year 5, then year 7 and 10 | 3 (prospective arm only) and 6 months (range 3–12 months) from start of MTX/TNFi |
Follow-up data items | - demographics - clinical data - current and previous JIA medication - drug start/stop dates - discontinuation reasons - adverse events | - demographics - clinical data - current and previous JIA medication - drug start/stop dates - discontinuation reasons - adverse events | - demographics - clinical data - results of imaging studies - medication history - medication start/stop dates - reasons for discontinuation | - demographics - clinical data - laboratory - medication history - drug start/stop dates |
Blood samples | Yes (untimed—added to study in 2010) | Yes (untimed—added to study in 2010) | Yes (untimed—at any point after enrolment if blood is being taken as part of routine clinical care) | Yes (Baseline, 6 months (range 3–12 months) for prospective arm; any timepoint for retrospective arm) |
Sample types collected | DNA, plasma, saliva | DNA, plasma, saliva | Plasma, RNA, DNA, synovial fluid | DNA, PBMC, serum |
Percentage of participants who have ever given a sample | 59% | 40% | 69% | 76% |