National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life (ReFLECT)

Pfizer

Status: Completed

Conditions: Psoriatic Arthritis; Ulcerative Colitis; Crohn Disease; Ankylosing Spondylitis; Rheumatoid Arthritis

Treatments: Other: QOL questionaire

Study type: Observational

Funder types: Industry

Identifiers

NCT02925338

C1231004

REFLECT

Details and patient eligibility

About

National, prospective, multicentre observational study designed for eligible patients treated with Inflectra.

Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.

Enrollment: 1,431 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis.
• Paediatric patients (children and adolescents between 6 and 17 years old) treated with Inflectra™, regardless of treatment phase from the time when Inflectra™ is prescribed in accordance with the indications listed in the SPC Crohn's Disease or ulcerative colitis Patients (or their legal representatives) who have received information (verbally and in writing) about the study and agreed to take part in it.
• Patients who have given their agreement for their clinical data and their medical file to be accessed by signing the information leaflet.

Exclusion criteria

• Patients who refuse access to their medical file for collection of: their medical data
• Patients not treated with Inflectra™.
• Patients treated with Inflectra™ for psoriasis.
• Patients with a past history of hypersensitivity to infliximab, to other murine proteins or to one of the excipients in Inflectra™.
• Patients with tuberculosis or any other severe infection such as sepsis, abscess or opportunistic infection .
• Patients with moderate to severe heart failure (NYHA III/IV)

Trial design

1,431 participants in 1 patient group

Patients treated with Inflectra

Treatment:

Other: QOL questionaire