Kliniske forsøg Nct side

Summary
EudraCT Number:2006-003142-42
Sponsor's Protocol Code Number:SC12267-3-2005
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2007-02-02
Trial results View results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2006-003142-42
A.3Full title of the trial
A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis
A.4.1Sponsor's protocol code numberSC12267-3-2005
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of Sponsor4SC AG
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.2Product code SC12267
D.3.4Pharmaceutical form Film-coated tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboFilm-coated tablet
D.8.4Route of administration of the placeboOral use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Active Rheumatoid Arthritis
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level PT
E.1.2Classification code 10039073
E.1.2Term Rheumatoid arthritis
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Primary Objective
The primary objective of this study is to evaluate the efficacy of SC12267 in patients with RA after a 12 week therapy, i.e. to.determine whether SC12267 at a daily dose of 35 mg or less demonstrates a better clinical response than that observed with placebo.
E.2.2Secondary objectives of the trial
The secondary objectives of this study are

•to evaluate the safety profile of SC12267 in patients with RA at doses up to 35 mg per day
•to evaluate the plasma concentration of SC12267 in patients with RA after once daily application (trough value)
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
6.2Subject Inclusion Criteria
Subjects meeting all of the following inclusion criteria will be considered for admission to the trial:
1.Regarding demographic data:
•Age:From 18 years
•Gender:Males and females
•Race:Caucasian
•BMI:19 - 30 kg/m2
2.Regarding RA:
•Patients with early active RA of functional classes I, II or III according to the criteria of American Rheumatism Association for RA
•DAS28(CRP) ≥ 4.1
(DAS28 formula with 4 variables using CRP)
3.Regarding previous medication for RA:
•DMARD-naive patients or DMARD-treated patients if the required wash-out periods are respected (refer to Subject Exclusion Criteria)
•Patients with stable oral corticosteroid therapy (dose  10 mg/day prednisolon equivalent)
4.Regarding general requirements
•Patients having sufficient intelligence to understand the nature of the study and are willing and able to communicate with the investigator and comply with all study requirements
•Patients willing to give informed consent in writing at enrolment into the study
•Males willing to use condoms or to be sexually abstinent in order to protect their female partners against potential contamination with the study medication via sperm fluid
•Females of childbearing potential willing to utilize two safe and independent methods of contraception one month before, throughout the course of the study and one month after termination of the study.
This must be a combination of the following:

1)a highly effective method of first choice = a method with a low failure rate (i.e. less than 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectables, some IUDs (Intra Uterine Device), vasectomised partner
together with
2)a method of second choice like condom, diapharagm or cup pessary.
E.4Principal exclusion criteria
6.3Subject Exclusion Criteria
Subjects presenting any of the following exclusion criteria cannot be admitted to the trial:
1.Regarding RA:
•Patients with RA of functional classes IV according to the criteria of American Rheumatism Association for RA
2.Regarding pre-treatment of RA and concomitant medication:
•History of treatment with one of the following drugs:
Leflunomide
Oral or injectable gold
Cyclophosphamide
Biologicals
(Abatacept, Etanercept, Adalimumab, Infliximab, Rituximab, Anakinra,)
•Receipt of the following drugs within 4 weeks prior to dosing:
Methotrexate
Sulfasalazine
Hydroxychloroquine
Azathioprine
Cyclosporine
Receipt of parenteral or intraarticular corticosteroids
Use of corticosteroids > 10 mg/day
3.Regarding treatment of RA:
•Non-pharmacological treatment (physical therapy)
4. Regarding concomitant diseases:
•Significant cardiac arrhythmia, bradycardia or tachycardia
•Any other significant finding in the ECG
•Congestive heart failure
•Uncontrolled arterial hypertension
•Haemoglobin < 8.5 mg/l
•White blood cell count < 3500/mm3
•Platelet count < 125 000/mm3
•Uncontrolled asthma
•History of HIV, Hepatitis B or C
•Liver enzyme levels outside the laboratory’s upper normal limit
•Serum creatinine level > 1.4 mg/dl
•Glomerular filtration rate < 50 ml / min / 1,73 m²
(Estimated GRF according to Cockroft-Gault, calculation see page 74)
•Renal disease
•History of or existence of urolithiasis
•Haematuria ( 10 Ery/field on dipsticks)
Exception: Females during menstruation
In this case a second examination after the end of menstruation will be performed.
•Psychiatric illness
•Active tuberculosis
•Known or suspected immunodeficiency
•History of malignancy within the past 5 years (excl. basal cell carcinoma of the skin)
•Inadequate contraception, pregnancy, lactation
•History of serious drug sensitivity
•History of alcohol dependence
•History of drug dependence
5.Regarding not permitted circumstances:
•Subject is a heavy smoker (more than 20 cigarettes per day)
•Participation in another investigational drug or vaccine trial within the last 3 months
•Vaccination with life attenuated viruses within 4 weeks prior to study start
•Patient with any medical condition which, in the opinion of the investigator or his designee, could jeopardize or compromise the ability of the patient to participate in the trial
•Patients possibly dependent on the investigator or the sponsor
E.5 End points
E.5.1Primary end point(s)
Primary Endpoint
The primary variable is the efficacy of SC12267 in patients with RA as assessed by the DAS28 with 4 variables including CRP (comparison of mean DAS28(CRP) differences between treatment groups) after 12 weeks of study duration.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned2
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA9
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial has a data monitoring committee Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months8
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial months8
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state12
F.4.2 For a multinational trial
F.4.2.1In the EEA 96
F.4.2.2In the whole clinical trial 120
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2006-11-30
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-10-26
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2007-10-08

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