Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Inflammation; Rheumatoid Arthritis
• Interventions: Drug: NNC 0141-0000-0100; Drug: placebo

• Registration Number: NCT01370902
• Lead Sponsor: Innate Pharma

Brief Summary

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-20
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation
• Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calculated with CRP (C-reactive protein) value) greater than or equal to 3.2
• Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control
• Males must be willing to use highly effective contraception
• Subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-dose (SD) trial part (i.v.)	placebo	-
Single-dose (SD) trial part (i.v.)	NNC 0141-0000-0100	-
Single-dose (SD) trial part (s.c.)	NNC 0141-0000-0100	-
Single-dose (SD) trial part (s.c.)	placebo	-
Multiple-dose (MD) trial part (s.c.)	placebo	-
Multiple-dose (MD) trial part (s.c.)	NNC 0141-0000-0100	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	from trial product administration to week 12

Secondary Outcome Measures

Name	Time	Method
Antibodies against NNC141-0100	from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - MD trial part	from trial product administration until final visit (week 12 or longer if applicable)
Area under the serum concentration-time curve - SD trial part	from trial product administration until final visit (week 12 or longer if applicable)
Terminal half-life (t½) - SD trial part	from trial product administration until final visit (week 12 or longer if applicable)