Remission Induction by Etanercept in Enthesitis related Arthritis JIA-Patients (juvenile undifferentiated Spondylarthropathy)

• Conditions: Active enthesitis-related arthrtitis as a category of juvenile idiopathic arthritis (ERA-JIA) as determined by International League of Associations for Rheumatology (ILAR) criteria.; MedDRA version: 14.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-020423-51-DE
• Lead Sponsor: Asklepios Klinik Sankt Augustin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-27
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Parents / legal guardian and patient are willing to participate in the study and signed voluntarily the Informed Consent form.

Parents / legal guardian are willing to actively supervise storage and administration of study drug and to ensure that the time of each dose is accurately recorded in the subject's diary.

Patient and parents / legal guardian agree to comply with study requirements and are able to be at the clinic for all required study visits.

Patient is at least 6 years old and has not reached his 18th birthday.

Patient is currently not treated with a disease-modifying antirheumatic drug (DMARD) or if the patient is treated with sulfasalazine and treatment is planned to be continued throughout the study period, stable dose of sulfasalazin has been given for at least 4 weeks. If patient has been treated with other DMARD (Methotrexate, Leflunomide, Azathiopine, Hydroxychloroquine, Chloroquine …) treatment has be discontinued at least 28 days before baseline. Stable dosage of NSAIDs or at least 4 weeks before baseline, stable dosage of corticosteroids (= 0.2 mg of prednisone per kilogram per day, with a maximum of 10 mg per day) for at least 4 weeks before baseline, or both are permitted.

IN FEMALE PATIENT IN WHOM MENARCHE HAS OCCURRED
•Negative serum pregnancy test prior to administration of study medication.
•Willingness to use an adequate method of contraception
Adequate contraception can include abstinence if the investigator deems appropriate.

Diagnosis of active ERA-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria. The activity of the disease is judged with
(I)a minimum of 3 active joints with either swelling not due to deformity or if no
swelling is present with limiting of motion and pain or pain on movement,
(II)a least a score of 3 of 10 for global assessment of the severity of disease by the physician
(III)a least a score of 3 of 10 for global assessment of overall well-being by the
patient or parent

Patient have to meet all criteria for eligibility for treatment with etanercept according to SPC and local guidelines, with expection of the requirement of a minimum of five affected joints.

Either the subject or an available adult must be capable (according to the investigator´s judgment of reconstituting and administering injections of SC etanercept.

Patient must be evaluated for active or latent TB infection according to the instructions of the protocol. If applicable: Guidelines regarding the treatment of latent TB must be followed prior to the administration of study medication.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening

Any preceding diagnosis of malignancy.
Pregnant or breast feeding female.
Female not willing to use appropriate contraception or sexual abstinence.

Active gastrointestinal disease (e.g., inflammatory bowel disease)

Significant blood clotting defect

Preceding diagnosis of tuberculosis or any opportunistic infection including herpes zoster at any time.

Patient has a history of any chronic disease other than JIA, especially chronic renal disease, liver disease, hematological, gastrointestinal, pulmonary, cardiological or neurological disease, which in the opinion of the investigator may influence the efficacy or safety of the study medication or which in the opinion of the investigator leads to an unacceptable risk for the patient if he participates in the study.

Patient had a significant illness during a period of 4 weeks prior to the first administration of study medication other than JIA-related.

Patient is abusing alcohol or drugs.

AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline

Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study

Patient plans to change dosing of oral corticosteroids within the study period.

Patient has received i.v., i.m., i.a. or soft tissue injections of corticosteroids within 4 weeks before first administration of study medication.

Patient has previously been admitted to this study.

Patient has been treated with any other investigational agent within 30 days or 5 half-lifes of the agent, whichever is longer, prior to the screening evaluation.

HIV infected
Known past or current hepatitis infection

Patient has a history of an expanding CNS neoplasm, active CNS infection, demyelinating disease, degenerative neurological disease or any progressive CNS disease.

Patient has a poorly controlled diabetes.

Received a live virus vaccine within 1 month prior to baseline

Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to tolerate the study drug or would make the patient unable to comply with the protocol.

Patient has a history of or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.

Patient has a recent history of alcohol or drug abuse within the past 6 months that would interfere with ability to comply with protocol requirements.

Any other inability to comply with the study requirements.

Any contraindication listed in the German 'Fachinformation' of the drug Enbrel®.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified