A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis
- Conditions
- Rheumatoid arthritisMedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2010-021283-14-PT
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. A diagnosis of RA according to the American College of Rheumatology (ACR1987
classification) made at least 3 month’s prior to screening.
2. Active RA, characterised by a DAS28-CRP =4.5 and = 5 swollen and = 5 tender joints of the 28 joint count
3. Methotrexate treatment (=7.5 mg - = 25 mg/week) for at least 12 weeks, with a stable dose for at least 4 weeks prior to screening
4. Aged between 18 and 75 years (both years inclusive)
5. Male and female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of study medication
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
1. Body mass index (BMI) < 18.5 or > 35.0 kg/m2
2. Subjects with chronic inflammatory autoimmune disease other than RA
3. History of or current inflammatory joint disease other than RA (e.g. gout, psoriatic or reactive arthritis, Lyme disease, juvenile ideopathic arthritis)
4. Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to screening
5. History of severe systemic bacterial, viral or fungal infections within the past 12 months prior to screening
6. Evidence of herpes zoster or cytomegalovirus infection that resolved less than 2 months prior to screening
7. Past or current malignancy
8. An adequate treatment duration of a biologic DMARD with an inadequate response (treatment failure) defined at the Investigator’s discretion
9. Clinically significant cardiac or cardiovascular disease
10. Positive for human immunodeficiency virus (HIV)
11. Positive test (serology and/or PCR) results for Hepatitis B or Hepatitis C
12. Positive purified protein derivative (PPD) tuberculin skin test
13. Blood donation or blood loss of more than 0.45 L within 2 months prior to screening, or longer if required by local regulations
14. Breast-feeding women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the change in disease activity following 12 weekly s.c. doses of NNC109-0012 3mg/kg compared to placebo in subjects with active RA on stable background MTX therapy.;Secondary Objective: • To assess signs of clinical efficacy as determined by change in disease activity (ACR<br>scores), clinical responses (EULAR response criteria) and PD biomarkers during and after 12 repeated doses of NNC109-0012<br>• To assess safety and tolerability during and after 12 repeated doses of NNC109-0012<br>• To assess the pharmacokinetic (PK) profile of NNC109-0012 after 12 repeated doses of NNC109-0012<br>• To assess potential immunogenicity of NNC109-0012 during and after 12 repeated doses of NNC109-0012.;Primary end point(s): Change in DAS28-CRP from baseline to week 12
- Secondary Outcome Measures
Name Time Method