A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis

Conditions: Rheumatoid arthritis
MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

Registration Number: EUCTR2010-019261-28-DE

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

• Men and women (not pregnant and not nursing) of =18 and =75 years of age
• Subjects with active RA characterised by a DAS28-CRP =4.5 and at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
• Ability to be examined by MRI
• Concomitant treatment with MTX (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing with trial product
• Having failed no biologic therapies for RA and no more than two non-biologic DMARDs
(primary or secondary failures to therapy)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Chronic inflammatory autoimmune disease other than RA
• Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation
• Body mass index (BMI) =18.0 or =40.0 kg/m^2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the change in disease activity following a single subcutaneous (s.c.) dose of NNC 142-0002 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy, measured 12 weeks after administration. ;Secondary Objective: To assess signs of clinical efficacy as determined by the change in disease activity, clinical responses, imaging and pharmacodynamic (PD) biomarkers. Further, safety, tolerability and quality of life will be assessed and the pharmacokinetics (PK), natural killer group 2 member D (NKG2D) receptor occupancy, and the immunogenicity of NNC 142-0002 will be measured. ;Primary end point(s): The primary endpoint is the change in the disease activity score 28 (DAS28) calculated with the C-reactive protein (CRP) value (i.e., DAS28-CRP), from baseline to Week 12.

Secondary Outcome Measures