Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Inflammation
Rheumatoid Arthritis

Treatments

Drug: anti-IL-20
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01038674
2009-013132-20 (EudraCT Number)
U1111-1112-6382 (Other Identifier)
NN8226-3704

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.

Enrollment

16 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Informed consent obtained before any trial-related activities
  • A diagnosis of rheumatoid arthritis made at least 3 months prior to screening
  • Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2
  • Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
  • Male subjects and female subjects of non-child bearing potential

Exclusion criteria

  • Body mass index (BMI) less than 18.5 or above 35.0 kg/m2
  • Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
  • History of or current inflammatory joint disease other than rheumatoid arthritis
  • Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
  • Past or current malignancy (as judged by the investigator)
  • Clinically significant cardiac or cardiovascular disease
  • Positive for human immunodeficiency virus (HIV), hepatitis or tuberculosis
  • Blood donation or blood loss of more than 0.45L within 2 months prior to study start, or longer if required by local regulations
  • Breast-feeding women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

16 participants in 2 patient groups, including a placebo group

Anti-IL-20
Experimental group
Treatment:
Drug: anti-IL-20
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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