Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565408
• Other study ID #: NN8828-3841
• Secondary ID: 2011-003037-33U1
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2012
• Last updated: February 6, 2017
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid arthritis (RA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• A diagnosis of RA, meeting the 2010 ACR-EULAR (American College of Rheumatology-European League Against Rheumatism) or the 1987 ACR classification criteria, made at least 4 months prior to trial drug administration

• Active RA, characterised by a DAS28-CRP equal to or above 4.5 and at least 5 tender and 5 swollen joints

• Methotrexate (MTX) treatment for at least 16 weeks (dose equal to or above 7.5 mg/week and equal to or below 25 mg/week) at a stable dose for at least 6 weeks prior to dosing

• Female subjects not pregnant and not nursing

Exclusion Criteria:

• Subjects with chronic inflammatory autoimmune disease other than RA

• Any active or ongoing chronic infectious disease requiring systemic anti-infectious treatment within 4 weeks prior to randomisation

• Body mass index (BMI) below 18.0 or above 35.0 kg/m^2

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• NNC0114-0006
Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks. The trial comprises dose escalation up to four dose levels. Progression to next dose will be based on safety evaluation.
• placebo
Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Russian Federation, 

References & Publications (1)

Wagner F, Skrumsager B, Fitilev S. Safety and tolerability of NNC0114-0006, an anti-IL-21 monoclonal antibody, at multiple s.c. dose levels in patients with rheumatoid arthritis. Arthritis and Rheumatology; 66 (10 (Supplement)): Abstract 1492

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		From first administration of trial product (week 1) and up until week 27
Secondary	Change in serum levels of total IL-21 from first administration of trial product		Week 1, week 27
Secondary	Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP)		From week 1 to week 9 (8 weeks after initiation of treatment)

External Links

•   Clinical Trials at Novo Nordisk