Patients with erosive/inflammatory hand osteoarthritis.
Conditions
Interventions
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 mill
Sponsors
Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Related to the study -Pregnant or breast-feeding. -Women of childbearing potential and sexually active not compliant with adequate contraceptive measures during the study. -Participation in any clinical investigation within 3 months prior to drug administration -Patients with scheduled surgery during the study. -History of drug abuse. -Patients with any restrictions related to the NMR test Related to the medical history: -History of malignancy within the last five years. -Fibromyalgia and / or chronic fatigue syndrome. -Uncontroled cardiovascular disease. -Clinical history of inflammatory or systemic diseases. -Secondary osteoarthritis such as chondrocalcinosis, Paget's disease, aseptic osteonecrosis, gout, ochronosis, acromegaly, hemochromatosis, Wilson's disease and osteochondromatosis -More intense pain in other part of the body that could interfere with the evaluation. -Poorly controlled diabetes mellitus, defined by a hemoglobin A1c>8%(25). -History of immunosuppression. -Acute or chronic infections requiring antibiotic treatment or serious fungal or viral infections (eg hepatitis, herpes zoster, HIV) -Major defects of clotting. -Active gastrointestinal disease. -Acute or chronic liver disease -Acute or chronic kidney disease with levels of blood urea nitrogen (BUN) or serum creatinine 2 times ULN or CrCl <30 ml / min at the screening visit. -History of significant medical conditions, which in the opinion of the investigator would preclude the patient from participating in this trial Related to the treatments: -Patients taking corticosteroids (oral or injectable), methotrexate, hydroxychloroquine or SYSADOA 12 weeks prior to inclusion. -Patients who have used intra-articular hyaluronic acid (in the hand of study) during the 24 weeks prior to the enrollment visit. -Patients undergoing radioactive synoviorthesis (in the hand of study) -Patients who have received any live virus vaccine within 12 weeks prior to starting the study (also not be allowed during the trial, including the 3 months following the last dose of study medication) -Patients treated with other bDMARDs (Biological Disease Modifying Anti-Rheumatic Drugs) -Patients treated with oral anticoagulants. -Patients with known hypersensitivity to any component of the study drugs. -Patients who have experienced asthma, urticaria or allergic reactions after administration of acetylsalicylic acid or NSAIDs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the changes observed by MRI on radiologic signs of osteoarticular inflammation (synovitis, bone edema, tenosynovitis and bone erosions).;Secondary Objective: To evaluate changes in pain, hand functionality and quality of life scale scores.;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.;Timepoint(s) of evaluation of this end point: The MRI will be performed at visits 0 and 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Contacts
Public ContactServicio de Reumatología
Hospital del Mar
Outcome results
None listed