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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: AZD5672; Drug: Etanercept; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713544

D1710C00009

Details and patient eligibility

About

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.

Enrollment: 373 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 of positive rheumatoid factor (blood test), current presence of positive rheumatoid factor (blood test), baseline radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies (bloo
• Be receiving either: Oral (tablets) or subcutaneous (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, etc).
• Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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373 participants in 6 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Etanercept

2

Experimental group

Description:

20mg

Treatment:

Drug: AZD5672

Drug: AZD5672

Drug: AZD5672

Drug: AZD5672

3

Experimental group

Description:

50mg

Treatment:

Drug: AZD5672

Drug: AZD5672

Drug: AZD5672

Drug: AZD5672

4

Experimental group

Description:

100mg

Treatment:

Drug: AZD5672

Drug: AZD5672

Drug: AZD5672

Drug: AZD5672

5

Experimental group

Description:

150mg

Treatment:

Drug: AZD5672

Drug: AZD5672

Drug: AZD5672

Drug: AZD5672

6

Placebo Comparator group

Treatment:

Drug: Placebo