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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 4 February 2013
Main ID:  EUCTR2007-003508-36-DE
Date of registration: 28/03/2008
Prospective Registration: Yes
Primary sponsor: Nitec Pharma AG
Public title: A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2
Scientific title: A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2
Date of first enrolment: 25/04/2008
Target sample size: 350
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003508-36
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Germany Hungary United Kingdom
Contacts
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Key inclusion & exclusion 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:
The presence of any of the following will exclude a patient from study enrolment:
•Suffering from another disease, which requires glucocorticoid treatment during the study period, e.g. asthma or neurodermatitis
•Synovectomy within 4 months prior to study start
•Use of glucocorticoids:
-Continued use of systemic glucocorticoids within 4 weeks prior to screening visit Visit 0)
-Intermittent use of glucocorticoids within 2 weeks prior to screening visit (Visit 0). Intermittent is defined as a maximum of 7 days treatment with a cumulative dose of = 100mg prednisone or equivalent within 6 weeks prior to Visit 0)
-Joint injections within 6 weeks prior to screening visit (Visit 0)
-Topical glucocorticoids, e.g. intra-nasal or inhaled glucocorticoids must be stopped at screening visit (Visit 0)
•Use of biologicals such as: tumor necrosis factor a (TNFa) inhibitors and other compounds within 5 serum half lives prior to screening visit (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 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 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.)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Intervention(s)

Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
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.
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.
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.
Secondary Outcome(s)
Secondary ID(s)
2007-003508-36-HU
NP01-007
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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