Pilot study to determine the efficacy of anakinra (antagonist of interleukin-1 receptor) administered for 3 months in improving inflammatory signs observed by MRI in patients with erosive/inflammatory hand osteoarthritis.

INTERVENTION: Trade Name: Kineret Product Name: NA Product Code: NA Pharmaceutical Form: Solution for infusion in pre‐filled syringe INN or Proposed INN: ANAKINRA CAS Number: 143090‐92‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for injection/infusion in pre‐filled syringe Route of administration of the placebo: Subcutaneous use CONDITION: Patients with erosive/inflammatory hand osteoarthritis. Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To evaluate the changes observed by MRI on radiologic signs of osteoarticular inflammation (synovitis, bone edema, tenosynovitis and bone erosions). Primary end point(s): The evaluation of changes observed on MRI radiologic signs of osteoarticular's disease. The two MRI performed will include imaging in axial, coronal and sagittal sections of the proximal and distal interphalangeal joints of the dominant hand with T1, T1 Fat‐Sat with gadolinium and T2 FAT‐SAT. ; Images will be scored according to the standard method of evaluation of erosive hand osteoarthritis by MRI. This assessment includes scoring of: ; ‐ Synovitis: 0‐3; ‐ Tenosynovitis of the flexor tendons: 0‐3; ‐ Bone edema: 0‐3, proximal/distal; ‐Ligamentous involvement injury: presence/absence of discontinuity; distal/proxima side.; ‐ Osteopyhtes (structual changes): 0‐3; distal/proximal; ‐ Subchondral cysts (structural changes): presence/absence; distal/proximal.; ‐ Joint space narrowing (structural changes): 0‐3; ‐ Bone erosion: 0‐3 distal/proximal; The scans will be reported by two expert radiologists experienced in musculoskeletal MRI, blinded to all clinical data. Secondary Objective: To evaluate changes in pain, hand functionality and quality of life scale scores. Timepoint(s) of evaluation of this end point: The MRI will be performed at visits 0 and 4. SECONDARY OUTCOME: Secondary end point(s): Changes on scores of pain, quality of life and function on osteoarthritis questionnaires: ; ‐VAS scale; ‐Quality of LifeQuestionnaire EuroQol‐5d; ‐AUSCAN hand function scale.; Hand strength measured by a cuff (previously inflated to 60 mmHg).; Security index evaluated by urine and blood analysis.; Analytical changes in inflammatory parameters. Timepoint(s) of evaluation of this end point: ‐ VAS and AUSCAN scales will be performed in all visits.; ‐ EuroQol‐5d will be performed at visits 0, 2, 4 and 6; ‐ Urine and blood analysis at visits ‐1, 1, 2, 3, 4 and 6; ‐ Pression force at visits 0, 1, 2, 3, 4, 5 and 6. INCLUSION CRITERIA: ‐Patients over 18 years at the moment of the selection visit. ‐Patients with erosive osteoarthritis of the interphalangeal joints with significant clinical activity acording to Anandarajah criteria. ‐ Important functional repercussions despite the conventional treatment reflected with a score 24 or more on the AUSCAN questionaire. ‐ Patients who can understand the study implications thus they are able to give the written 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15