A randomised, double blind, placebo-controlled trial with multiple doses of Anti-IL-20 in subjects with rheumatoid arthritis

• Conditions: Rheumatoid arthritis; MedDRA version: 13.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-021283-14-HU
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-27
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

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