A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Etanercept; Drug: AZD9056; Drug: Placebo

• Registration Number: NCT00520572
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-23
• Study First Posted: 2007-08-24
• Study Completion: 2009-03
• Results First Submitted: 2010-07-22
• Results First Submitted QC: 2010-09-15
• Results First Posted: 2010-10-04
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

• Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). At least one of the following: documented history and current presence of positive rheumatoid factor (blood test), baseline radiographic erosion.

Be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate for at least 6 months prior to randomisation.

Exclusion Criteria

• Any other inflammatory disease in addition to RA that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, e t c). Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. Persistently abnormal liver function enzymes (blood test).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Etanercept	Etanercept 50mg, subcutaneous, once weekly
2	AZD9056	50mg oral, once daily
3	AZD9056	100 mg oral, once daily
6	Placebo	oral, once daily
4	AZD9056	200 mg oral, once daily
5	AZD9056	400mg once, daily

Primary Outcome Measures

Name	Time	Method
American College of Rheumatology 20 Response (ACR20) at 6 Months	6 months	The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment

Secondary Outcome Measures

Name	Time	Method
American College of Rheumatology 50 Response (ACR50) at 6 Months	6 months	The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment.
American College of Rheumatology 70 Response (ACR70) at 6 Months	6 months	The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.	Baseline to 6 months	Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of disease activity; and ESR) after 6 months' treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. (The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms).
Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.	Baseline to 6 months	Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months' treatment, calculated as score at 6 months minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. (The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability).

Trial Locations

Locations (1)

Research Site; 🇸🇰 Piestany, Slovakia