Clinical trial NCT01647451: A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammation
Rheumatoid Arthritis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-07-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)
timeFrame: Week 0, week 12
Secondary outcomes:
measure: ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
timeFrame: Week 12
measure: Incidence of adverse events (AEs)
timeFrame: Up to week 24
measure: Incidence of antibodies against NNC0114-0006
timeFrame: Up to Week 24
measure: Terminal serum half-life (t½)
timeFrame: After second dose administration at week 6
measure: Change in serum levels of total interleukin-21 (IL-21)
timeFrame: Up to week 12
measure: Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI)
timeFrame: Week 0, week 12
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sevlievo
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szikszó
country: Hungary
facility: Novo Nordisk Investigational Site
city: Veszprém
country: Hungary
facility: Novo Nordisk Investigational Site
city: Riga
country: Latvia
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Bydgoszcz
country: Poland
facility: Novo Nordisk Investigational Site
city: Bytom
country: Poland
facility: Novo Nordisk Investigational Site
city: Elblag
country: Poland
facility: Novo Nordisk Investigational Site
city: Katowice
country: Poland
facility: Novo Nordisk Investigational Site
city: Poznan
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Kazan
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Kursk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Skt Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Skt Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Skt. Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Skt. Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Niska Banja
country: Serbia
facility: Novo Nordisk Investigational Site
city: A Coruña
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Elche
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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