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SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis

NCT01010581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2012-03-01

No results posted yet for this study

Summary

The purpose of the study is to determine the efficacy, safety and pharmacokinetics of SC12267 (4SC-101, 35 mg) in combination with methotrexate in comparison to methotrexate alone in the treatment of patients suffering from Rheumatoid Arthritis.

Conditions

Interventions

DRUG

SC12267 (4SC-101)

oral administration

DRUG

Placebo

oral administration

DRUG

Methotrexate

oral administration

DRUG

Folic Acid

oral administration

Sponsors & Collaborators

  • 4SC AG

    lead INDUSTRY

Principal Investigators

  • Stanisław Sierakowski, Prof. MD · Centrum Miriada, Prywatny Gabinet Specjalistyczny, Bialystok, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-04-30
Completion
2011-07-31

Countries

  • Bulgaria
  • Czechia
  • Poland
  • Romania

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 NCT01010581 on ClinicalTrials.gov