CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 373 enrolled
Drug / intervention
AZD5672 +5 moredrug
Likely dose
AZD5672 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00713544
NCT00713544Phase 2Completed
CompareCT.gov

A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.

AstraZeneca·interventional·Posted Jul 11, 2008·Updated Oct 3, 2011

In Brief

A Phase 2 clinical trial evaluating AZD5672, Etanercept, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 373 participants across 49 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Colombia, Czechia, Hungary, Italy, Latvia, Malta, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2008
Enrollment StartJul 1, 2008
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.0 years ago

Interventions

AZD5672drug

20 mg oral, once daily

Etanerceptdrug

50 mg, subcutaneous injection, weekly

Placebodrug

placebo, oral, once daily

AZD5672drug

50 mg oral, once daily

AZD5672drug

100 mg oral, once daily

AZD5672drug

150 mg oral, once daily