NCT01636843|TerminatedPhase 2

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN8226-36132012-000610-11U1111-1127-9324

Study Type

interventional

Target

298

Locations

14 countries

Sites

139

Timeline

RegisteredJul 2012

StartedOct 2012

CompletionNov 2014

Brief Summary

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

298

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2012

Geographic Reach

14 countries

139 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

July 6, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed

4 months until next milestone

Study Start

First participant enrolled

October 30, 2012

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2014

Completed

Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

July 6, 2012

Last Update Submit

September 3, 2018

Conditions

Inflammation Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)
At week 12 (responder or non-responder)

Secondary Outcomes (10)

ACR20, ACR50 and ACR70 improvement of ACR score from baseline
At weeks 12 and 24
Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline
At weeks 12 and 24
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
At weeks 12 and 24
European League Against Rheumatism (EULAR) criteria response
At weeks 12 and 24
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)
At weeks 12 and 24
+5 more secondary outcomes

Study Arms (4)

60 mg

EXPERIMENTAL

Drug: NNC0109-0012

120 mg

EXPERIMENTAL

Drug: NNC0109-0012

240 mg

EXPERIMENTAL

Drug: NNC0109-0012

Placebo

EXPERIMENTAL

Drug: placebo

Interventions

NNC0109-0012DRUG

Administered subcutaneously (s.c., under the skin), once weekly.

120 mg240 mg60 mg

placeboDRUG

Administered subcutaneously (s.c., under the skin), once weekly.

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.