Study identification

EU PAS number

EUPAS20781

Study ID

47271

Official title and acronym

An observational post-approval safety study of golimumab in treatment of polyarticular Juvenile Idiopathic Arthritis (pJIA) using the German Biologics JIA Registry (BiKeR)

DARWIN EU® study

No

Study countries

Germany

Study description

Simponi® (golimumab, GLM) received European marketing authorization for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) on 24 June 2016.
In connection with the approval in this indication, the Sponsor is committed to conduct a required postauthorization safety study (PASS) to monitor long-term safety of GLM in the treatment of pJIA in regular clinical practice setting.
This is an observational PASS and will monitor safety and effectiveness of GLM use in the treatment of pJIA in usual clinical practice using data from the German Biologics JIA Registry (Biologika in der Kinderrheumatologie, BiKeR). The study will comprise four study cohorts: GLM cohort, contemporary anti-tumor necrosis factor (anti-TNF) control cohort (including adalimumab ADA, etanercept ETA, or their biosimilars when available), contemporary methotrexate (MTX) control cohort, and historic anti-TNF control cohort (ADA or ETA).
The primary objectives are to describe the baseline clinical and demographic characteristics of the four study cohorts, to evaluate long-term safety of GLM in treatment of pJIA, and to compare the risks of primary safety endpoints in GLM cohort with those in contemporary anti-TNF cohort (primary comparison) and with those in contemporary MTX cohort (secondary comparison), adjusted for baseline characteristics.

The study is transferred from Merck Sharp & Dohme to Janssen Pharmaceutica NV

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Gerd Horneff

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Janssen Pharmaceutica NV
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)