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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Etanercept; Drug: AZD9056

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520572

D1520C00001

Details and patient eligibility

About

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

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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385 participants in 6 patient groups, including a placebo group

1

Active Comparator group

Description:

Etanercept 50mg, subcutaneous, once weekly

Treatment:

Drug: Etanercept

2

Experimental group

Description:

50mg oral, once daily

Treatment:

Drug: AZD9056

3

Experimental group

Description:

100 mg oral, once daily

Treatment:

Drug: AZD9056

4

Experimental group

Description:

200 mg oral, once daily

Treatment:

Drug: AZD9056

5

Experimental group

Description:

400mg once, daily

Treatment:

Drug: AZD9056

6

Placebo Comparator group

Description:

oral, once daily

Treatment:

Drug: Placebo