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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Inflammation; Rheumatoid Arthritis

Treatments: Drug: placebo; Drug: NNC0114-0006

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565408

U1111-1122-4067 (Other Identifier)

NN8828-3841

2011-003037-33 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

NNC0114-0006

Experimental group

Treatment:

Drug: NNC0114-0006

Placebo

Placebo Comparator group

Treatment:

Drug: placebo