Clinical trial NCT00713544: A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
RA
AZD5672
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: American College of Rheumatology 20 Response (ACR20)
timeFrame: 12 weeks
Secondary outcomes:
measure: American College of Rheumatology 50 Response (ACR50)
timeFrame: 12 weeks
measure: American College of Rheumatology 70 Response (ACR70)
timeFrame: 12 weeks
measure: Disease Activity Score (Based on 28 Joint Count) (DAS28)
timeFrame: Baseline to 12 Weeks
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Baseline to 12 Weeks
Other outcomes:
Locations:
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Bucaramanga
country: Colombia
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
city: Ceska Lipa
country: Czech Republic
facility: Research Site
city: Ceske Budejovice
country: Czech Republic
facility: Research Site
city: Hlucin
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Praha 11 - Chodov
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Mako
country: Hungary
facility: Research Site
city: Sopron
country: Hungary
facility: Research Site
city: Siena
country: Italy
facility: Research Site
state: SI
city: Valmiera
country: Latvia
facility: Research Site
city: Birkirkara
country: Malta
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Dzialdowo
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Saint-petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Niska Banja
country: Serbia
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Piestany
country: Slovakia
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
state: Gauteng
city: Durban
country: South Africa
facility: Research Site
state: Kwazulu Natal
city: Cape Town
country: South Africa
facility: Research Site
state: Western Cape
city: Donetsk
country: Ukraine
facility: Research Site
city: Ivano-frankivsk
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Simferopol
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Mark Layton
role: STUDY_DIRECTOR
affiliation: University of Amsterdam
name: Paul P Tak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.