A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647451
• Other study ID #: NN8828-3842
• Secondary ID: 2011-005376-42U1
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2012
• Last updated: February 6, 2017
• Start date: September 2012
• Est. completion date: August 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 the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2013
• Est. primary completion date: August 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 (American College of Rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (If the diagnosis was made prior to 2010, a diagnosis meeting the 1987 ACR classification criteria is acceptable)

• Active RA characterised by DAS28-CRP (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count

• Concomitant treatment with MTX above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (MTX doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)

• Biologic naïve subjects or subjects having been treated with biologics for RA (biologic experienced) provided they meet one of the following criteria: a. Reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. Discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)

Exclusion Criteria:

• Body mass index (BMI) below or equal to 18.0 or above or equal to 38.0 kg/m^2

• Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome). Subjects with secondary Sjögren's syndrome or stable hypothyroidism are eligible

• Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)

• Any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)

• History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• NNC0114-0006
Two i.v. (intravenous) doses administered 6 weeks apart.
• placebo
Two i.v. (intravenous) doses administered 6 weeks apart.

Locations

Country	Name	City	State
Bulgaria	Novo Nordisk Investigational Site	Plovdiv
Bulgaria	Novo Nordisk Investigational Site	Sevlievo
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Sofia
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Debrecen
Hungary	Novo Nordisk Investigational Site	Debrecen
Hungary	Novo Nordisk Investigational Site	Szikszó
Hungary	Novo Nordisk Investigational Site	Veszprém
Latvia	Novo Nordisk Investigational Site	Riga
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Bydgoszcz
Poland	Novo Nordisk Investigational Site	Bytom
Poland	Novo Nordisk Investigational Site	Elblag
Poland	Novo Nordisk Investigational Site	Katowice
Poland	Novo Nordisk Investigational Site	Poznan
Poland	Novo Nordisk Investigational Site	Warszawa
Russian Federation	Novo Nordisk Investigational Site	Kazan
Russian Federation	Novo Nordisk Investigational Site	Kursk
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Skt Petersburg
Russian Federation	Novo Nordisk Investigational Site	Skt Petersburg
Russian Federation	Novo Nordisk Investigational Site	Skt. Petersburg
Russian Federation	Novo Nordisk Investigational Site	Skt. Petersburg
Russian Federation	Novo Nordisk Investigational Site	Yaroslavl
Serbia	Novo Nordisk Investigational Site	Belgrade
Serbia	Novo Nordisk Investigational Site	Belgrade
Serbia	Novo Nordisk Investigational Site	Niska Banja
Spain	Novo Nordisk Investigational Site	A Coruña
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Elche
Spain	Novo Nordisk Investigational Site	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Latvia,  Poland,  Russian Federation,  Serbia,  Spain, 

References & Publications (1)

Canete J, Leszczynski P, Riisbro R, Frederiksen K. Efficacy and safety of NNC0114-0006, an anti-IL-21 monoclonal antibody, in patients with active rheumatoid arthritis. Arthritis and Rheumatology; 66 (10 (Supplement)): Abstract 947

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)		Week 0, week 12
Secondary	ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)		Week 12
Secondary	Incidence of adverse events (AEs)		Up to week 24
Secondary	Incidence of antibodies against NNC0114-0006		Up to Week 24
Secondary	Terminal serum half-life (t½)		After second dose administration at week 6
Secondary	Change in serum levels of total interleukin-21 (IL-21)		Up to week 12
Secondary	Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI)		Week 0, week 12

External Links

•   Clinical Trials at Novo Nordisk