CompletedPhase 3

Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan

Japan23 participantsStarted 2013-08-09

Plain-language summary

The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to Methotrexate or biologics

Who can participate

Age range4 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥2 active joints (e.g. presence of swelling, or if no swelling is present, limitation of motion (LOM) accompanied by pain, tenderness, or both) at screening and at Week 0 (Day 1).
✓. ≥2 joints with LOM at screening and at Week 0 (Day 1).

What they're measuring

Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16

Timeframe: Week 16 (Day 113)

Trial details

NCT IDNCT01835470

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11-24

Results submitted2016-11-15

View on ClinicalTrials.gov More Juvenile Idiopathic Arthritis trials