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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00713544
First received: July 9, 2008
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: AZD5672
Drug: Etanercept
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • American College of Rheumatology 20 Response (ACR20) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 12 Weeks' treatment.


Secondary Outcome Measures:
  • American College of Rheumatology 50 Response (ACR50) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 12 Weeks' treatment.

  • American College of Rheumatology 70 Response (ACR70) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 12 Weeks' treatment.

  • Disease Activity Score (Based on 28 Joint Count) (DAS28) [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
    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 12 Weeks' 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) [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
    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 12 Weeks 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.


Enrollment: 373
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Etanercept
50 mg, subcutaneous injection, weekly
Other Name: Enbrel
Experimental: 2
20mg
Drug: AZD5672
20 mg oral, once daily
Experimental: 3
50mg
Drug: AZD5672
50 mg oral, once daily
Experimental: 4
100mg
Drug: AZD5672
100 mg oral, once daily
Experimental: 5
150mg
Drug: AZD5672
150 mg oral, once daily
Placebo Comparator: 6 Drug: Placebo
placebo, oral, once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713544

  Show 50 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Layton AstraZeneca
Principal Investigator: Paul P Tak, MD, PhD VU University of Amsterdam
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00713544     History of Changes
Other Study ID Numbers: D1710C00009
Study First Received: July 9, 2008
Results First Received: July 22, 2010
Last Updated: August 26, 2011
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Netherlands: Medicines Evaluation Board (MEB)
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Ukraine: Ministry of Health

Keywords provided by AstraZeneca:
Rheumatoid Arthritis
RA
AZD5672

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 20, 2014