A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis
- Conditions
- Rheumatoid ArthritisMedDRA version: 12.0Level: LLTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2009-012953-39-BG
- Lead Sponsor
- 4SC AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 244
1. Patients with active RA
2. Age > 18 years
3. Gender: Males and females
4. Patients with active RA of functional classes I, II or III according to the criteria of American Rheumatism Association for RA
5. DAS28(ESR) = 4.5 (DAS28 formula with 4 variables using ESR)
6. Patients who have received weekly doses of MTX (10–25 mg/week) for a minimum of 3 months prior to Day 1 dosing, and who have received a stable MTX dose of 10–25 mg/week without any change in route or change in folic acid supplementation for at least 6 weeks prior to Day 1 dosing
7. Patients may receive up to 10 mg/day of oral prednisolone or steroid equivalent. Dose must have been stable for at least 30 days and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements.
8. 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
9. Patients willing to give informed consent in writing at enrolment into the study
10. Males willing to utilize safe methods of contraception
11. Females of childbearing potential willing to utilize two safe and independent methods of contraception throughout the course of the study
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
Subjects presenting any of the following exclusion criteria cannot be admitted to the trial:
1. Patients with RA of functional classes IV according to the criteria of American Rheumatism Association for RA
2. Patients who have received any of the following treatments must abide by the indicated washout period:
- Leflunomide requires a 6 month washout period prior toDay 1 dosing
- Oral or injectable gold, azathioprine, penicillamine, anakinra require a 30 day washout period prior to Day 1 dosing
- Cyclosporine, abatacept, etanercept, adalimumab, infliximab, and rituximab require a 60 day washout period prior to Day 1 dosing
- Cyclophosphamide requires a 180 day washout period prior to Day 1 dosing
- Parenteral or intra-articular corticosteroids require a 30 day washout period prior to Day 1 dosing
3. Receipt of the following drugs within 4 weeks prior to dosing:
- Sulfasalazine
- Hydroxychloroquine
- Use of corticosteroids > 10 mg/day
4. Non-pharmacological treatment (physical therapy)
5. Significant cardiac arrhythmia, bradycardia or tachycardia
6. Any other significant finding in the ECG
7. Congestive heart failure (with exception of NYHA I and II if adequately compensated by medical treatment)
8. Uncontrolled arterial hypertension
9. Haemoglobin < 8.0 g/dl
10. White blood cell count < 3500/mm3
11. Platelet count < 125 000/mm3
12. Uncontrolled asthma
13. History of HIV, Hepatitis B or C
14. Liver enzyme levels > twice the laboratory’s upper normal limit
15. Serum creatinine level > 1.5 mg/dl
16. Glomerular filtration rate < 50 ml / min / 1,73 m² (estimated GRF according to Cockroft-Gault)
17. Renal disease or conditions after kidney transplantation
18. History of or existence of urolithiasis
19. Haematuria (> 10 Ery/field on dipsticks) Exception: Females during menstruation
In this case a second examination after the end of menstruation will be performed
20. Psychiatric illness
21. Active tuberculosis
22. Known or suspected immunodeficiency
23. History of malignancy within the past 5 years (excl. basal cell carcinoma of the skin)
24. Inadequate contraception, pregnancy, lactation
25. History of serious drug sensitivity
26. History or existing alcohol and drug dependence
27. Subject is a heavy smoker (more than 20 cigarettes per day)
28. Participation in another investigational drug or vaccine trial within the last 3 months
29. Vaccination with life attenuated viruses within 4 weeks prior to study start
30. 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
31. Patients possibly dependent on the investigator or the sponsor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The primary variable is the efficacy of combination therapy of SC12267 with MTX in patients with RA as assessed by the ACR20 differences between treatment group and placebo group after 13 weeks of study duration.;Main Objective: • to evaluate the efficacy of SC12267 in combination with<br>methotrexate in patients with RA;Secondary Objective: • to evaluate the safety of the combination of SC12267 and<br>methotrexate in patients with RA<br>• to evaluate the plasma concentration (trough value) of<br>SC12267 after once daily application in combination with<br>methotrexate after weekly administration
- Secondary Outcome Measures
Name Time Method