A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2009-011791-30-GB
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-14
• Study Completion: 2013-02-06
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification), made at least three months prior to randomisation.
• Active RA, characterized by a DAS28 score =3.2
• Male and female subjects
• Age between 18 and 75 years (both inclusive)
• Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks prior to dosing
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

1. Known or suspected allergy to trial product or related products
2. Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)
3. History of or current inflammatory joint disease other than RA (eg. gout (crystal proven), psoriatic, juvenile arthritis), current reactive arthritis or Lyme disease
4. Body mass index (BMI) <18.0 or >38.0 kg/m² (inclusive)
5. Chronic or ongoing active infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to randomisation
6. History of severe systemic bacterial, viral or fungal infections within the past 12 months prior to randomisation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified