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Completed

NCT Number: NCT01565408

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

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).

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Key information

Conditions

Inflammation Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC0114-0006

Drug

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

Drug

Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks.

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: From first administration of trial product (week 1) and up until week 27

Secondary outcomes

  1. Change in serum levels of total IL-21 from first administration of trial product

    Time frame: Week 1, week 27

  2. Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP)

    Time frame: From week 1 to week 9 (8 weeks after initiation of treatment)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2012
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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