Efficacy and safety of anakinra (antagonist of the interleukin-1 receptor) in the treatment of periarticular inflammation in patients refractory to NSAID and / or steroids
- Conditions
- Inflammation in periarticular structures in patients refractory to NSAIDs and / or corticosteroids.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-005402-65-ES
- Lead Sponsor
- Institut de Recerca HSCSP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
- Male and female patients over 18 years of age at the time of the screening visit.
- Supraspinatus tendonitis, plantar fasciitis, trochanteric bursitis and / or lateral epicondylitis patients refractory to NSAIDs and / or corticosteroids, lack or loss of efficacy or contraindications.
- Patients with a score on the VAS pain score greater than or equal to 6 cm
- Patients able to understand the implications of the study and demonstrate it through voluntary signing of informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Pregnancy or breast-feeding
- Participation in any clinical investigation within 3 months prior to drug administration.
- Elective surgery patients during the trial.
- History of drug or alcohol abuse during the 12 months prior to drug administration.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of anakinra in the treatment of periarticular inflammation in patients refractory to NSAID and / or steroids.;<br> Secondary Objective: - To evaluate the safety of Anakinra: recording of adverse events and monitoring of biochemical analysis.<br> - Determine the number of injections per patient.<br> - Determine the number of patients who need more than one injection of Anakinra.<br> - Determine the number of patients who needed rescue medication.<br> - To determine the dose of rescue medication per patient.<br> - Evaluate the action of anakinra in inflammation by an imaging test (ultrasound).<br> ;Primary end point(s): - Evaluation of the patient's pain by VAS (0-10);Timepoint(s) of evaluation of this end point: Basal, + 7 , +15, +30 and +60 days
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Basal, + 7 , +15, +30 and +60 days;<br> Secondary end point(s): - Adverse Events.<br> - Number of injections per patient.<br> - Number of patients needed more than one injection.<br> - Number of patients need to take paracetamol for pain in the affected area.<br> - Total dose paracetamol in patients who have needed to alleviate pain in the affected area.<br> - Ultrasound results<br>