A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2011-005376-42-ES
• Date of registration: 29/03/2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis
• Scientific title: A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis
• Date of first enrolment: 18/06/2012
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005376-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Global Clinical Registry (GCR, 1452
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR, 1452
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
- A diagnosis of RA meeting the 2010 ACR 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 ? 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 ? 15 mg/week for at least 4 months prior to screening, with stable dose of ? 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)
- Females and males with age between 18 and 75 years (both included)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion criteria:
- Body mass index (BMI) ?18.0 or ?38.0 kg/m2
- 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., brochiectasis, chronic osteomyelitis)
- History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rheumatoid arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Code: 0114-0006B
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: NNC0114-0006
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)

Secondary Objective: - To describe the safety and tolerability of NNC0114-0006
- To describe the immunogenicity of NNC0114-0006
- To describe the pharmacokinetics (PK) of NNC0114-0006
- To compare the pharmacodynamic (PD) effects of NNC0114-0006 and placebo on various biomarkers, including markers on disease activity and structural damage
- To compare effects of NNC0114-0006 and placebo on patient reported outcomes (PROs)

Main Objective: 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

Timepoint(s) of evaluation of this end point: From baseline to Week 12

Secondary Outcome(s)

Secondary end point(s): 1- ACR20/50/70
2- Incidence of adverse events (AEs)
3- Incidence of antibodies against NNC0114-0006
4- Terminal serum half-life (t½)
5- Change in serum levels of total IL-21
6- Change in Health Assessment Questionnaire ? Disability Index score (HAQ-DI)

Timepoint(s) of evaluation of this end point: 1- At Week 12
2- Up to Week 24
3- Up to Week 24
4- After second dose administration at Week 6
5- Up to Week 12
6- From baseline to Week 12

Secondary ID(s)

2011-005376-42-LV

NN8828-3842

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date: 11/05/2012
Contact:

Results

• Results available: Yes
• Date Posted: 28/07/2015
• Date Completed: 26/08/2013
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005376-42/results