Study to evaluate anakinra efficacy in patients with hand's osteoarthritis.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.