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A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX

NCT02270632 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-06-12

No results posted yet for this study

Summary

A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX.

Conditions

Interventions

DRUG

F8IL10

F8IL10 will be administered once a week for 8 weeks (or until withdrawn from the study).

DRUG

MTX

All patients enrolled in the study will receive as concomitant therapy MTX at stable dose (10-25 mg/week), and the corresponding fixed dose of folic acid.

DRUG

Placebo

Placebo will be administered once a week for 8 weeks (or until withdrawn from the study).

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2019-04-30
Completion
2023-06-08

Countries

  • Germany
  • Italy
  • Switzerland

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 NCT02270632 on ClinicalTrials.gov