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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD5672
Etanercept
Placebo
AZD5672
AZD5672
AZD5672
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA, AZD5672

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

5

6

Arm Description

20mg

50mg

100mg

150mg

Outcomes

Primary Outcome Measures

American College of Rheumatology 20 Response (ACR20)
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)
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)
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)
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)
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.

Full Information

First Posted
July 9, 2008
Last Updated
August 26, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00713544
Brief Title
A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
Acronym
ESCAPE
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, RA, AZD5672

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
373 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
20mg
Arm Title
3
Arm Type
Experimental
Arm Description
50mg
Arm Title
4
Arm Type
Experimental
Arm Description
100mg
Arm Title
5
Arm Type
Experimental
Arm Description
150mg
Arm Title
6
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD5672
Intervention Description
20 mg oral, once daily
Intervention Type
Drug
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
50 mg, subcutaneous injection, weekly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo, oral, once daily
Intervention Type
Drug
Intervention Name(s)
AZD5672
Intervention Description
50 mg oral, once daily
Intervention Type
Drug
Intervention Name(s)
AZD5672
Intervention Description
100 mg oral, once daily
Intervention Type
Drug
Intervention Name(s)
AZD5672
Intervention Description
150 mg oral, once daily
Primary Outcome Measure Information:
Title
American College of Rheumatology 20 Response (ACR20)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
American College of Rheumatology 50 Response (ACR50)
Description
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.
Time Frame
12 weeks
Title
American College of Rheumatology 70 Response (ACR70)
Description
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.
Time Frame
12 weeks
Title
Disease Activity Score (Based on 28 Joint Count) (DAS28)
Description
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.
Time Frame
Baseline to 12 Weeks
Title
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Description
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.
Time Frame
Baseline to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Layton
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul P Tak, MD, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Blagoevgrad
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Bogota
Country
Colombia
Facility Name
Research Site
City
Bucaramanga
Country
Colombia
Facility Name
Research Site
City
Medellin
Country
Colombia
Facility Name
Research Site
City
Ceska Lipa
Country
Czech Republic
Facility Name
Research Site
City
Ceske Budejovice
Country
Czech Republic
Facility Name
Research Site
City
Hlucin
Country
Czech Republic
Facility Name
Research Site
City
Pardubice
Country
Czech Republic
Facility Name
Research Site
City
Praha 11 - Chodov
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
Country
Czech Republic
Facility Name
Research Site
City
Zlin
Country
Czech Republic
Facility Name
Research Site
City
Bekescsaba
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Kecskemet
Country
Hungary
Facility Name
Research Site
City
Mako
Country
Hungary
Facility Name
Research Site
City
Sopron
Country
Hungary
Facility Name
Research Site
City
Siena
State/Province
SI
Country
Italy
Facility Name
Research Site
City
Valmiera
Country
Latvia
Facility Name
Research Site
City
Birkirkara
Country
Malta
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Dzialdowo
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Sopot
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Ploiesti
Country
Romania
Facility Name
Research Site
City
Saint-petersburg
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Niska Banja
Country
Serbia
Facility Name
Research Site
City
Banska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Piestany
Country
Slovakia
Facility Name
Research Site
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Durban
State/Province
Kwazulu Natal
Country
South Africa
Facility Name
Research Site
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Ivano-frankivsk
Country
Ukraine
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Simferopol
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
20662070
Citation
Gerlag DM, Hollis S, Layton M, Vencovsky J, Szekanecz Z, Braddock M, Tak PP; ESCAPE Study Group. Preclinical and clinical investigation of a CCR5 antagonist, AZD5672, in patients with rheumatoid arthritis receiving methotrexate. Arthritis Rheum. 2010 Nov;62(11):3154-60. doi: 10.1002/art.27652.
Results Reference
derived

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

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