Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Inflammation; Rheumatoid Arthritis
• Interventions: Drug: NNC109-0012; Drug: placebo

• Registration Number: NCT01282255
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-21
• Study First Posted: 2011-01-24
• Study Start: 2011-02
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Disposition First Submitted: 2012-05-10
• Disposition First Submitted QC: 2012-05-10
• Disposition First Posted: 2012-05-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Czech Republic: Age between 18 - 65 years (both inclusive)
• A diagnosis of RA made at least 3 months prior to trial start
• Active RA
• Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start
• Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication
• Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode

Exclusion Criteria

• Known or suspected allergy to trial product or related products
• Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m^2
• Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	NNC109-0012	-
B	placebo	-

Primary Outcome Measures

Name	Time	Method
Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)	week 0, week 12

Secondary Outcome Measures

Name	Time	Method
Terminal serum half-life (t½)	end of treatment period
Serum levels of NNC109-0012	end of treatment period

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Norwich, United Kingdom