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

NCT00713544 | Completed Phase 2 Results

• 1 other identifier: D1710C00009
• Study Type: interventional
• Target: 373
• Locations: 14 countries
• Sites: 49

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; RA; AZD5672

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (4)

• American College of Rheumatology 50 Response (ACR50)

  12 weeks

• American College of Rheumatology 70 Response (ACR70)

  12 weeks

• Disease Activity Score (Based on 28 Joint Count) (DAS28)

  Baseline to 12 Weeks

• Health Assessment Questionnaire - Disability Index (HAQ-DI)

  Baseline to 12 Weeks

Study Arms (6)

1

ACTIVE COMPARATOR

Drug: Etanercept

2

EXPERIMENTAL

20mg

Drug: AZD5672

3

EXPERIMENTAL

50mg

Drug: AZD5672

4

EXPERIMENTAL

100mg

Drug: AZD5672

5

EXPERIMENTAL

150mg

Drug: AZD5672

6

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD5672 DRUG

20 mg oral, once daily

2

Etanercept DRUG

50 mg, subcutaneous injection, weekly

Also known as: Enbrel

1

Placebo DRUG

placebo, oral, once daily

6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (49)

Research Site

Blagoevgrad, Bulgaria

Location

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Medellín, Colombia, Colombia

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Bogotá, Colombia

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Bucaramanga, Colombia

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Česká Lípa, Czechia

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České Budějovice, Czechia

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Hlučín, Czechia

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Pardubice, Czechia

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Prague, Czechia

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Praha 11 - Chodov, Czechia

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Zlín, Czechia

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Békéscsaba, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Kecskemét, Hungary

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Makó, Hungary

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Sopron, Hungary

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Siena, SI, Italy

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Valmiera, Latvia

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Birkirkara, Malta

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Bialystok, Poland

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Działdowo, Poland

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Krakow, Poland

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Lublin, Poland

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Sopot, Poland

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Szczecin, Poland

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Torun, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Brasov, Romania

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Bucharest, Romania

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Ploieşti, Romania

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Saint Petersburg, Russia

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Yaroslavl, Russia

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Belgrade, Serbia

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Niška Banja, Serbia

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Piešťany, Slovakia

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Cape Town, Western Cape, South Africa

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Donetsk, Ukraine

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Ivano-Frankivsk, Ukraine

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Kiev, Ukraine

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Kyiv, Ukraine

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Simferopol, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 20662070 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide; Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

Hybrid ACR, ACRn, individual ACR components, Erythrocyte sedimentation rate (ESR), Short-form-36 (SF-36), Rheumatoid Arthritis Quality of Life (RAQoL) and Patient Insight Questionnaire (PIQ) did not provide extra information so are not presented

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Mark Layton

  AstraZeneca

  STUDY DIRECTOR

• Paul P Tak, MD, PhD

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 3, 2011
• Results First Posted: October 3, 2011

Record last verified: 2011-08

Locations

BU (3); MA (1); RU (2); PL (9); HU (6); RO (3); SE (2); SL (3); ZA (3); UA (5); CO (3); LA (1); CZ (7); IT (1)