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A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease

NCT04004429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-07-10

Study results available
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Summary

This is a multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) \> 22, who are to start up-titration with methotrexate.

Conditions

Interventions

DRUG

50 mg AP1189

50 mg AP1189 powder in bottle

DRUG

AP1189

100 mg AP1189 powder in bottle

DRUG

Placebo

Placebo powder in bottle

Sponsors & Collaborators

  • SynAct Pharma Aps

    lead INDUSTRY

Principal Investigators

  • Ellen-Margrethe Hauge, Professor · Aarhus University Hospital

  • Espen A Haavardsholm, Concultant, PhD · Diakonhjemmet Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-26
Primary Completion
2021-11-16
Completion
2021-11-16

Countries

  • Denmark
  • Norway

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04004429 on ClinicalTrials.gov