Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis (SINCERE)

Viatris

Status

Terminated

Conditions

Arthritis, Juvenile Rheumatoid

Treatments

Drug: Celecoxib

Drug: nsNSAIDs

Study type

Observational

Funder types

Industry

Identifiers

NCT00688545

A3191344

Details and patient eligibility

About

This multi-center observational Registry will collect long-term safety data on patients treated with celecoxib or non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) as used in clinical practice for the treatment of Juvenile Idiopathic Arthritis (JIA).

Full description

None Study has been terminated early (LSLV = 09Jan2012) due to release of the postmarketing commitment by the US FDA. The study was stopped for futility/change in treatment paradigm that minimizes chronic NSAID use and not for safety concerns.

Enrollment

275 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age at least 2 years but less than 18 years; JIA of any of the following subtypes: oligoarthritis, polyarthritis, or stable systemic disease;
new treatment (started not more than 6 months prior) with one NSAID (celecoxib or nsNSAID).

Exclusion criteria

Patients with the following JIA subtypes: active systemic disease, psoriatic Arthritis, enthesitis-related Arthritis, or undifferentiated arthritis;
Patients with Reiter's syndrome; patients unlikely to complete 2 years of follow up;
Patients who need to use multiple NSAIDs at the same time.