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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-003142-42-DE
• Date of registration: 02/02/2007
• Prospective Registration: No
• Primary sponsor: 4SC AG
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 30/11/2006
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003142-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
6.2 Subject 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.
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:
6.3 Subject 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active Rheumatoid Arthritis
MedDRA version: 8.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis

Intervention(s)

Product Code: SC12267
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: 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.

Secondary Objective: 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)

Primary 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.

Secondary ID(s)

SC12267-3-2005