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

• Conditions: Rheumatoid arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-005376-42-HU
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-11
• Last Update Posted: 9 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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., bronchiectasis, chronic osteomyelitis)
- History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified