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A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis

NCT00713544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 373

Last updated 2011-10-03

Study results available
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Summary

This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.

Conditions

Interventions

DRUG

AZD5672

20 mg oral, once daily

DRUG

Etanercept

50 mg, subcutaneous injection, weekly

DRUG

Placebo

placebo, oral, once daily

DRUG

AZD5672

50 mg oral, once daily

DRUG

AZD5672

100 mg oral, once daily

DRUG

AZD5672

150 mg oral, once daily

Sponsors & Collaborators

Principal Investigators

  • Mark Layton · AstraZeneca

  • Paul P Tak, MD, PhD · University of Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Bulgaria
  • Colombia
  • Czechia
  • Hungary
  • Italy
  • Latvia
  • Malta
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00713544 on ClinicalTrials.gov