Ensayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis

Phase 1

• Conditions: Artritis idiopática juvenil activa de curso poliarticular/Polyarticular-course juvenile idiopathic arthritis.; MedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritis

• Registration Number: EUCTR2009-011593-15-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-29
• Study Completion: 2013-01-28
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

1. Documented evidence of polyarticular-course juvenile idiopathic arthritis (pcJIA):
?Rheumatoid Factor Positive or Rheumatoid Factor Negative JIA polyarthritis subset (pJIA) for at least 6 months -or -
?extended oligoarticular JIA (eoJIA) with active polyarticular course for at least 6 months
prior to study entry according to ILAR Criteria
2. Polyarticular-course JIA requiring presence of active disease with at least five joints with active arthritis (joints that are swollen or if no swelling is present limitation of movement accompanied by pain tenderness or both) at both screening and baseline (with a least three of the active joints having limitation of motion).
3. Age 2 years up to and including age 17 years at the time of enrollment
4. Must meet one of the following:
?Have had an inadequate response to MTX or
?Inability to tolerate MTX
5. Must meet one of the following:
?not receiving MTX for at least 4 weeks prior to baseline visit, -or-
?taking MTX for at least 12 weeks immediately prior to the baseline visit and on a stable dose of ?10 to ?20 mg/m2 for at least 8 weeks prior to the baseline visit, together with either folic acid or folinic acid.
6. Must meet one of the following:
?Not currently receiving oral corticosteroids ?or-
?taking oral corticosteroids at a stable dose for a minimum of 4 weeks prior to the baseline visit at no more than 10 mg/day or 0.2 mg/kg/day whichever is less;
8. Must meet one of the following:
?Not taking NSAIDs ?or-
?taking no more than 1 type of NSAID at a stable dose for a minimum of 2 weeks prior to the baseline visit and is less than or equal to the maximum recommended daily dose;
9. Must meet one of the following
?Never treated with biologics ?or-,
?If previously treated must have discontinued anakinra ? 1 week prior to baseline, etanercept ? 2 weeks prior to baseline, rilonacept ? 5 weeks prior to baseline, infliximab or adalimumab ? 8 weeks prior to baseline, abatacept ? 12 weeks prior to baseline or canakinumab ? 20 weeks prior to baseline.
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

1. Wheelchair bound or bedridden or has little or no ability for self-care;
2. Any other auto-immune, rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets; Rheumatoid Factor Positive polyarticular JIA, Rheumatoid Factor Negative polyarticular JIA, and extended oligoarticular JIA. The excluded illnesses include but are not limited to systemic juvenile idiopathic arthritis, Lyme disease, enthesitis-related arthritis; psoriatic arthritis, Reiter?s syndrome, systemic lupus erythematosus, infectious or reactive arthritis or parvovirus infections
3. History of significant allergic or infusion reactions to prior biologic therapy;
4. Evidence of serious uncontrolled concomitant diseases including but not limited to the cardiovascular, pulmonary, nervous, renal, hepatic or endocrine system
5. Any active acute, subacute, chronic or recurrent bacterial, mycobacterial, viral or systemic fungal infection or opportunistic infection
6. Active TB requiring treatment within 2 years prior to screening visit or currently active TB;
7. Positive PPD at screen unless chest radiograph is negative for active tuberculosis at screen and patient treated with anti-tuberculosis therapy for at least 4 weeks prior to receiving study medication
8. Any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit;
9. Known active current or history of recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infections, (e.g. bronchiectasis, ), an open or draining or infected skin wound, sinusitis, recurrent urinary tract infection ( e.g. recurrent pyelonephritis )
10. History or concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn?s disease, ulcerative colitis or other symptomatic lower gastrointestinal conditions, including ulcer and perforation;
11. Active uveitis (absence of uveitis must be documented by a slit lamp ophthalmology examination within 12 weeks prior to baseline).
12. Previous treatment with tocilizumab;
13. Serum creatinine >1.5 ULN (upper limit of normal for age and sex);
14. AST or ALT > 1.5 ULN (upper limit of normal for age and sex);
15. Total bilirubin > 1.3 mg/dL (> 23 umol/L);
16. Platelet count < 150 x 10e3/µL (< 150,000/mm3);
17. Hemoglobin < 9.0 g/dL (< 3.7 mmol/L);
18. WBC count < 5,000/mm3 (< 5.0 x 10e9/L);
19. Neutrophil count < 2,500/ mm3 (< 2.5 x 10e9/L);

Study & Design

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