Study on Structum® in Adult Patients with Osteoarthritis (TRUST)

Pierre Fabre

Status: Active, not recruiting

Conditions: Osteoarthritis, Knee

Treatments: Drug: Chondroitin sulfate

Study type: Observational

Funder types: Industry

Identifiers

NCT06623773

NIS13559

Details and patient eligibility

About

Chondroitin sulfate (CS) is a SYSADOA and a natural biomacromolecule belonging to the class of glycosaminoglycans. CS is a major component of the extracellular matrix (ECM), where it constitutes an essential component of proteoglycans.

To this date, no real-world studies have been conducted to precisely describe the burden associated with OA among patients treated with CS.Therefore, an observational, descriptive, prospective, national study will be conducted to describe the burden associated with OA and the quality of life of patients treated with Structum® in Poland.

Full description

This is an observational, descriptive, national, multicentric, prospective, longitudinal study, which will be conducted over a 6-month follow-up period for each patient. The study will not provide or recommend any specific treatment or procedures.

All patients affected by OA in the knee, for whom Structum® is prescribed in a participating center, will be screened in a consecutive manner for eligibility. The study will focus exclusively on patients with OA in the knee as this is the joint most frequently affected and most easily assessed for OA patients.

Two additional data collections can be anticipated for these patients as part of their standard of care follow-up visits, which will usually occur around 3 and 6 months after the initial study visit.The patient enrolment period is expected to be 6 months, with a total study duration of 12 months.

Enrollment: 150 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged 50 to 80 years at inclusion

• of knee OA (either a patient newly diagnosed [at inclusion] or with history of knee OA) based on at least the following items 1 and/or 2:

  1. knee pain lasting for at least 3 months;
  2. patient in the active phase of knee OA disease (knee pain score ≥ 40mm at inclusion on the Visual Analog Scale [VAS] 0-100 mm);
  3. knee radiographs showing knee joint narrowing and/or osteophytes.

• Patients who have been prescribed, for the first time or not, Structum®.

• If patient is taking any NSAIDs or other analgesics, patient could be on stable dose at least one week before inclusion to the study.

• Patients able to visit the clinic and attend follow-up visits.

• Patients having signed an informed consent form, according to local regulations.

Exclusion criteria

• Patients with any ongoing chondroitin sulfate treatment at inclusion or during the last 3 months.
• plasma (in the last 3 months). No glucocorticoids administration in the last 3 months before inclusion. That does not include NSAIDS, paracetamol and other analgesic medications (e.g. tramadol).
• Patients with an artificial knee joint, including unilateral.
• Patients scheduled to undergo knee replacement surgery in the next 6 months.
• Patients with a severe general condition that prevents them from being included in the study as assessed by the investigator.
• Patients participating in interventional trials on investigational drugs at the time of inclusion.