We randomly allocated patients to treatment with IVIG or placebo. Children received either saline or intravenous immunoglobulin (IVIG) [ImmunoRel™ (batch 20081217)] at a dose of 400mg/kg/day for 5 days or an equivalent volume of 0.9% normal saline given intravenous at the rate of 0.01 to 0.02 ml/kg body weight/minute. All investigators, care providers and participants were blinded of the study drug. A second sealed envelope was kept with the patient's notes in case a physician urgently needed to know which drug a patient had received.

Japanese Encephalitis

IVIG group received 400mg/kg/day intravenous at the rate of 0.01 to 0.02 ml/kg body weight/minute for 5 days or appearance of side effect or adverse events.
Placebo group received 0.9% saline intravenous at similar rate.

Intravenous immunoglobulin [ImmunoRel™ (batch 20081217)]

Kanti Children's Hospital

BP Koirala Institute of Health Sciences

Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

A Randomized Double Blind Placebo Controlled Trial to Assess the Safety and Efficacy of Intravenous Immunoglobulin (IVIG) in Children With Japanese Encephalitis in Nepal

Patients will be monitored for side effects such as infusion site reaction, diarrhea, rise in blood pressure (in mm Hg) and change in urinary output (in ml/Kg/hour) every 12 hours from first day of commencing treatment until until death or discharge. Patient on average are administered the study drug on the first day of admission. The study drug is administered daily for 5 days. Patients are discharged on an average on eighth day (192 hours) of hospital admission.

At the time of discharge(expected average of eighth day of admission) or death: Time to death, to recover from coma, to sit independently, to stand independently, to walk at least 5m independently, and to leave hospital.
At 6 months after discharge: history of further seizures, behavioral changes, evidence of recovery of neurological sequelae such as assessment of ability to sit independently, to stand independently, to walk at least 5 meters independently.

Pre-treatment was immediately prior to the first dose of study drug on the first day, mid-treatment was immediately prior to the 4th dose and post-treatment was 1hour after administering the fifth dose of the study drug.

Ajit Rayamajhi

Clinical Research Fellow (PhD Student)

University of Liverpool

B.P. Koirala Institute of Health Sciences

Juvenile Idiopathic Arthritis (JIA)
Systemic Lupus Erythematosis
Juvenile Dermatomyositis
Scleroderma
Overlap Syndromes
Sjogren's syndrome
Sarcoidosis
Systemic Vasculitis (excluding Kawasaki's disease and Henoch-Schonlein Purpura)
Systemic vasculitis as defined by the Chapel Hill Concensus Conference on Nomenclature. Other forms of systemic vasculitis, including Giant cell (temporal) arteritis, Takayasu's arteritis, Polyarteritis nodosa, Wegener's granulomatosis, Churg-Strauss syndrome, Microscopic polyangiitis, Essential cryoglobulinemic vasculitis, Cutaneous leukocytoclastic angiitis, Behcet's disease, Other vasculitis
Other rheumatic disease

Nephrotic syndrome will be classified according to the following categories:
Idiopathic nephrotic syndrome, without renal biopsy histology, presumed minimal change disease (MCD), Focal segmental glomerulosclerosis (FSGS), confirmed on biopsy, Minimal change disease, confirmed on biopsy Nephrotic syndrome with Henoch-Schonlein Purpura (HSP).

Acute Lymphoblastic Leukemia

Nephrotic Syndrome

Rheumatism

Alberta Children's Hospital

Stollery Children's Hospital

BC Children's Hospital

Winnipeg Children's Hospital

IWK Health Centre

McMaster Children's Hospital

London Health Sciences Centre

Children's Hospital of Eastern Ontario

Hospital for Sick Children

Shriners Hospital for Children

Montreal Children's Hospital

Hopital Sainte Justine

Steroid-Induced Osteoporosis in the Pediatric Population - Canadian Incidence Study

Steroid-Induced Osteoporosis in the Pediatric Population - Canadian Incidence Study (STOPP-CIS)

We will determine the magnitude and rate of total body, hip and lumbar spine bone mass deficits following initiation of glucocorticoid therapy, in relation to glucocorticoid dose and duration, among children with leukemia, rheumatic conditions and nephrotic syndrome. The longitudinal pattern of deficits (or gains) in bone mass will be determined for each disease state by plotting bone mass measurements taken at 6 month intervals throughout the study, with an additional 3 month measurement being recorded for patients with nephrotic syndrome.

To identify whether a glucocorticoid threshold dose exists for each of the three disease categories, above which significant deficits in bone mass are likely to occur.

To assess the frequency of atraumatic fractures in relation to glucocorticoid dose and duration for each of the three chronic illnesses.

To determine the fracture risk associated with a given reduction in bone mass from baseline, for each of the three chronic diseases.

To determine the magnitude of bone mass restitution when glucocorticoid therapy is withdrawn, and to evaluate whether recovery is age- and/or pubertal stage-dependent.

To investigate the relationship between handedness and lateralization of bone density.

Dr. Leanne Ward

Director, Pediatric Bone Health Clinical and Research Programs

Canadian Institutes of Health Research (CIHR)

Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone

MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.

Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms

1Prednison

MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.

2Prednison MTX

Total

Sex: Female, Male

Region of Enrollment

The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment.

Prednison1

Prednison Methotrexate 2

The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.

Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures

Overall Study

Rheumatology Institute Prague

1 Prednison

2 Prednison Methotrexate

Polymyositis

Dermatomyositis

Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms

Prednisone

Methotrexate

Revmatologicky ustav

Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM

A Prospective, Randomised, Assessor-blind, Multicenter Study of Efficacy and Safety of Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With Polymyositis and Dermatomyositis.

Institute of Rheumatology, Prague

Karolinska Institutet

Patients with known or suspected Idiopathic Inflammatory myopathies (IIM)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Study and Treatment of Inflammatory Muscle Diseases

Studies on the Natural History and Pathogenesis of Polymyositis, Dermatomyositis, and Related Diseases

To determine its utility in differentiating different muscle diseases, in identifying early extra muscular involvement of muscle diseases, in characterizing the pattern of muscle involvement for the diseases studied, and whether it can serve as a diagnostic tool to better identify muscle inflammation and atrophy.

dermatomyositis/edema

Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

Steroid-Induced Osteoporosis in the Pediatric Population - Canadian Incidence Study

Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM

Study and Treatment of Inflammatory Muscle Diseases

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