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A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

NCT00902369 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2016-07-25

No results posted yet for this study

Summary

This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study

Conditions

Interventions

DRUG

AK106-001616

Part1: Dose escalation Part2: Dose expansion

DRUG

Placebo

DRUG

Active comparator

Sponsors & Collaborators

  • Asahi Kasei Pharma Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-10-31
Completion
2010-07-31

Countries

  • Czechia
  • Germany
  • Hungary
  • Lithuania
  • Romania
  • United Kingdom

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 NCT00902369 on ClinicalTrials.gov