Rheumatoid ArthritisPhase 2ESCAPENCT00713544

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

A Phase 2 study testing AZD5672 and Etanercept in people with Rheumatoid Arthritis, run by AstraZeneca at 49 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: AZD5672 and Etanercept
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 373 participants
Where: 49 sitesin 14 countries
Study dates: Jul 2008to Apr 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

49 sites in 14 countries.

Country

City, postcode or hospital

49 sites in 14 countries

Poland9 sites

Research Site
Bialystok
Research Site
Działdowo
Research Site
Krakow
Research Site
Lublin
Research Site
Sopot
Research Site
Szczecin
Research Site
Torun
Research Site
Warsaw
Research Site
Wroclaw

Other trials in Poland

Czechia7 sites

Research Site
Česká Lípa
Research Site
České Budějovice
Research Site
Hlučín
Research Site
Pardubice
Research Site
Prague
Research Site
Praha 11 - Chodov
Research Site
Zlín

Other trials in Czechia

Hungary6 sites

Research Site
Békéscsaba
Research Site
Budapest
Research Site
Debrecen
Research Site
Kecskemét
Research Site
Makó
Research Site
Sopron

Other trials in Hungary

Ukraine5 sites

Research Site
Donetsk
Research Site
Ivano-Frankivsk
Research Site
Kiev
Research Site
Kyiv
Research Site
Simferopol

Other trials in Ukraine

Bulgaria3 sites

Research Site
Blagoevgrad
Research Site
Plovdiv
Research Site
Sofia

Other trials in Bulgaria

Colombia3 sites

Research Site
Bogotá
Research Site
Bucaramanga
Research Site
Medellín, Colombia

Other trials in Colombia

Romania3 sites

Research Site
Brasov
Research Site
Bucharest
Research Site
Ploieşti

Other trials in Romania

Slovakia3 sites

Research Site
Banská Bystrica
Research Site
Bratislava
Research Site
Piešťany

Other trials in Slovakia

South Africa3 sites

Research Site
Cape Town, Western Cape
Research Site
Durban, KwaZulu-Natal
Research Site
Pretoria, Gauteng

Other trials in South Africa

Russia2 sites

Research Site
Saint Petersburg
Research Site
Yaroslavl

Other trials in Russia

Serbia2 sites

Research Site
Belgrade
Research Site
Niška Banja

Other trials in Serbia

Italy1 site

Research Site
Siena, SI

Other trials in Italy

Latvia1 site

Research Site
Valmiera

Other trials in Latvia

Malta1 site

Research Site
Birkirkara

Other trials in Malta

About this study

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.

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
Being tested: AZD5672, Etanercept, Placebo
Keywords: Rheumatoid Arthritis, RA, AZD5672
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD5672Drug
20 mg oral, once daily
EtanerceptDrug
Also called Enbrel
50 mg, subcutaneous injection, weekly
PlaceboDrug
placebo, oral, once daily
AZD5672Drug
50 mg oral, once daily
AZD5672Drug
100 mg oral, once daily
AZD5672Drug
150 mg oral, once daily

Study groups in NCT00713544
Study group	Role	What they receive
1	Active comparator	Not described Receives: Drug: Etanercept
2	Experimental	20mg Receives: Drug: AZD5672
3	Experimental	50mg Receives: Drug: AZD5672
4	Experimental	100mg Receives: Drug: AZD5672
5	Experimental	150mg Receives: Drug: AZD5672
6	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Secondary outcomes (4)

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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: Baseline to 12 Weeks
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.
Measured: Baseline to 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Apr 2009

First posted11 Jul 2008 (estimated)
Study startJul 2008
Primary completionApr 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 373 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00713544
Sponsor's protocol ID: D1710C00009
Acronym: ESCAPE
Status last verified: Aug 2011
First submitted: 9 Jul 2008
Last updated: 3 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 20662070

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00713544
Acronym / sponsor ID: ESCAPE / D1710C00009
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, RA, AZD5672
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 373 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 11 Jul 2008 (estimated)
Results: Posted 3 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
1	Active comparator	Drug: Etanercept
2	Experimental	Drug: AZD567220mg
3	Experimental	Drug: AZD567250mg
4	Experimental	Drug: AZD5672100mg
5	Experimental	Drug: AZD5672150mg
6	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD567220 mg oral, once daily	Drug	2
EtanerceptAlso: Enbrel50 mg, subcutaneous injection, weekly	Drug	1
Placeboplacebo, oral, once daily	Drug	6
AZD567250 mg oral, once daily	Drug	3
AZD5672100 mg oral, once daily	Drug	4
AZD5672150 mg oral, once daily	Drug	5

Primary outcome

American College of Rheumatology 20 Response (ACR20)
Time frame: 12 weeks
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.

4 secondary outcomes

American College of Rheumatology 50 Response (ACR50)
Time frame: 12 weeks
American College of Rheumatology 70 Response (ACR70)
Time frame: 12 weeks
Disease Activity Score (Based on 28 Joint Count) (DAS28)
Time frame: Baseline to 12 Weeks
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time frame: Baseline to 12 Weeks

Results and safety

Results posted to the registry on 3 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD5672 20 mg	52	45
AZD5672 50 mg	52	46
AZD5672 100 mg	52	41
AZD5672 150 mg	76	66
Placebo	65	57
Etanercept	76	67

Primary outcome: American College of Rheumatology 20 Response (ACR20)

Time frame: 12 weeks. Number. Unit: Participants

Measure	AZD5672 20 mg n = 52	AZD5672 50 mg n = 52	AZD5672 100 mg n = 51	AZD5672 150 mg n = 76	Placebo n = 65	Etanercept n = 75
Value	20	15	17	34	25	58

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD5672 20 mg	0 of 52 (0%)	12 of 52 (23.1%)	Not reported
AZD5672 50 mg	1 of 52 (1.9%)	11 of 52 (21.2%)	Not reported
AZD5672 100 mg	2 of 51 (3.9%)	15 of 51 (29.4%)	Not reported
AZD5672 150 mg	2 of 76 (2.6%)	21 of 76 (27.6%)	Not reported
Placebo	1 of 65 (1.5%)	15 of 65 (23.1%)	Not reported
Etanercept	0 of 75 (0%)	16 of 75 (21.3%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20662070Gerlag 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.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Layton study director

AstraZeneca

Paul P Tak, MD, PhD principal investigator

University of Amsterdam

49 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD5672 and Etanercept in people with Rheumatoid Arthritis, run by AstraZeneca at 49 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in Poland, Czechia, Hungary, Ukraine, Bulgaria and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

American College of Rheumatology 20 Response (ACR20) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00713544, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2011.