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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005402-65-ES

Enrollment

Registered

2014-04-25

Start date

2015-01-19

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation in periarticular structures in patients refractory to NSAIDs and / or corticosteroids.

Interventions

Trade Name: Kineret Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ANAKINRA CAS Number: 143090-92-0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of anakinra in the treatment of periarticular inflammation in patients refractory to NSAID and / or steroids.; Secondary Objective: - To evaluate the safety of Anakinra: recording of adverse events and monitoring of biochemical analysis. - Determine the number of injections per patient. - Determine the number of patients who need more than one injection of Anakinra. - Determine the number of patients who needed rescue medication. - To determine the dose of rescue medication per patient. - Evaluate the action of anakinra in inflammation by an imaging test (ultrasound). ;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	—

Measure

Time frame

Main Objective: To evaluate the efficacy of anakinra in the treatment of periarticular inflammation in patients refractory to NSAID and / or steroids.; Secondary Objective: - To evaluate the safety of Anakinra: recording of adverse events and monitoring of biochemical analysis. - Determine the number of injections per patient. - Determine the number of patients who need more than one injection of Anakinra. - Determine the number of patients who needed rescue medication. - To determine the dose of rescue medication per patient. - Evaluate the action of anakinra in inflammation by an imaging test (ultrasound). ;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

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Basal, + 7 , +15, +30 and +60 days; Secondary end point(s): - Adverse Events. - Number of injections per patient. - Number of patients needed more than one injection. - Number of patients need to take paracetamol for pain in the affected area. - Total dose paracetamol in patients who have needed to alleviate pain in the affected area. - Ultrasound results	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Basal, + 7 , +15, +30 and +60 days; Secondary end point(s): - Adverse Events. - Number of injections per patient. - Number of patients needed more than one injection. - Number of patients need to take paracetamol for pain in the affected area. - Total dose paracetamol in patients who have needed to alleviate pain in the affected area. - Ultrasound results

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Countries

Spain

Contacts

Public ContactRomy Rodriguez

Institut de TRecerca HSCSP

rrodriguezmu@santpau.cat34939329190001969

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026