Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Trade Name: Lodotra®
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: MBq/mg megabecquerel(s)/milligram
Concentration type: equal
Concentration numbe
Sponsors
Nitec Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Provide written informed consent •Have a documented history of RA (sero-negative or sero-positive) in agreement with the ACR criteria including the symptoms morning stiffness, joint pain, tender and swollen joints, inflammatory state with elevated erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) •Be on disease modifying anti-rheumatic drugs (DMARD) treatment for RA for at least 6 months, with a stable dose for at least 6 weeks prior to screening visit (Visit 0) •Have duration of morning stiffness of at least 45 minutes •Have swollen joint count of 4 or more out of 28 •Have tender joint count of 4 or more out of 28 •Aged 18 to 80 years •Female patients of childbearing potential must be using a medically accepted contraceptive regimen •Able to perform the required study procedures including handling of medication containers and diaries 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a patient from study enrolment: •Suffering from another disease, which requires glucocorticoid treatment, e.g. asthma, neurodermatitis •Synovectomy within 4 months prior to study start •Use of glucocorticoids (by any route) within 6 weeks prior to screening visit (Visit 0) •Prior use of biologicals: TNFa inhibitors within 3 months prior to screening visit (Visit 0) or other compounds within 1 year prior to screening Visit 0 •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation •Pregnancy or nursing •Participation in another clinical study (use of an investigational product) within 30 days preceding visit (Visit 0) •Re-entry of patients previously enrolled in this trial •Suspected inability or unwillingness to comply with study procedures •Alcohol or drug abuse •Requirement of nonpermitted concomitant medication •Known hypersensitivity to prednisone or predniso(lo)ne •Any contraindication for low dose prednisone treatment •Significant renal impairment (serum creatinine > 150 µmol/L) •Significant hepatic impairment (investigator’s opinion) •Any uncontrolled concomitant disease requiring further clinical evaluation (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate if 12 weeks of treatment with 5 mg Lodotra® administered in the evening is superior to placebo in terms of the ACR20 responder rate.;Secondary Objective: The key secondary objective of this study is to evaluate if 12 weeks of treatment with 5 mg MR prednisone (Lodotra®) administered in the evening is superior to placebo in terms of the relative reduction of morning stiffness. Additional secondary objectives of this study are to compare 12 weeks of treatment with 5 mg Lodotra® administered in the evening with placebo in terms of efficacy, quality of life and safety. ;Primary end point(s): The primary efficacy variable will be the ACR20 responder rate after 12 weeks of double-blind treatment with the study medication. Responders will be defined as those whose improvement from baseline to endpoint (12 weeks) fulfill all three of the following criteria: •= to or >20% reduction in the tender joint count (0–28) •= to or >20% reduction in the swollen joint count (0–28) •= to or >20% reduction in 3 of 5 of the following additional measures: -Patient assessment of pain (VAS) -Patient’s global assessment of disease activity (VAS) -Physician’s global assessment of disease activity (VAS) -HAQ-DI -CRP or ESR as acute-phase reactant. CRP will be used if the CRP value at baseline (Visit 1; Week 0) is above the ULN; otherwise the ESR value will be used to calculate the ACR20 responder status. | — |
Countries
Germany, Hungary, United Kingdom
Outcome results
None listed