Rheumatoid ArthritisPhase 2NCT00520572

A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

A Phase 2 study testing AZD9056 and Etanercept in people with Rheumatoid Arthritis, run by AstraZeneca at 51 sites in 12 countries.

Completed

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

Official record

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Trial summary

The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: AZD9056 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: 385 participants
Where: 51 sitesin 12 countries
Study dates: Aug 2007to Mar 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 and current presence of positive rheumatoid factor (blood test), baseline radiographic erosion.
Be receiving either oral (tablets) or subcutaneous/intramuscular (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, e t c). Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. Persistently abnormal liver function enzymes (blood test).

Trial locations and contacts

51 sites in 12 countries.

Country

City, postcode or hospital

51 sites in 12 countries

Poland9 sites

Research Site
Bialystok
Research Site
Elblag
Research Site
Katowice
Research Site
Krakow
Research Site
Lublin
Research Site
Poznan
Research Site
Sopot
Research Site
Torun
Research Site
Warsaw

Other trials in Poland

United States8 sites

Research Site
Aventura, Florida
Research Site
Olympia, Washington
Research Site
Orlando, Florida
Research Site
Petoskey, Michigan
Research Site
Portland, Oregon
Research Site
Sarasota, Florida
Research Site
Syracuse, New York
Research Site
Tampa, Florida

Other trials in United States

Mexico6 sites

Research Site
Cd. Juarez
Research Site
Chihuahua City
Research Site
Guadalajara
Research Site
Mexico City
Research Site
Tapachula
Research Site
Tijuana

Other trials in Mexico

Romania6 sites

Research Site
Brasov, Brașov County
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Iași
Research Site
Ploieşti
Research Site
Sf. Gheorghe

Other trials in Romania

Argentina5 sites

Research Site
Buenos Aires
Research Site
Córdoba
Research Site
Planta Baja San Juan
Research Site
Rosario, Santa Fe Province
Research Site
San Miguel de Tucumán

Other trials in Argentina

Australia4 sites

Research Site
George Town
Research Site
Victoria Park, Western Australia
Research Site
Woodsville, South Australia
Research Site
Woolloongabba, Queensland

Other trials in Australia

Czechia3 sites

Research Site
Prague
Research Site
Uherské Hradiště
Research Site
Zlín

Other trials in Czechia

France3 sites

Research Site
Bobigny
Research Site
Bordeaux
Research Site
Tours

Other trials in France

Slovakia3 sites

Research Site
Bansky Bystrica
Research Site
Bratislava
Research Site
Piešťany

Other trials in Slovakia

Canada2 sites

Research Site
St. John's, Newfoundland and Labrador
Research Site
Winnipeg, Manitoba

Other trials in Canada

Belgium1 site

Research Site
Hasselt

Other trials in Belgium

Russia1 site

Research Site
Saint Petersburg

Other trials in Russia

About this study

Official title: A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine

Conditions: Rheumatoid Arthritis
Being tested: AZD9056, Etanercept, Placebo
Keywords: Rheumatoid Arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

AZD9056Drug
EtanerceptDrug
PlaceboDrug

Study groups in NCT00520572
Study group	Role	What they receive
1	Active comparator	Etanercept 50mg, subcutaneous, once weekly Receives: Drug: Etanercept
2	Experimental	50mg oral, once daily Receives: Drug: AZD9056
3	Experimental	100 mg oral, once daily Receives: Drug: AZD9056
4	Experimental	200 mg oral, once daily Receives: Drug: AZD9056
5	Experimental	400mg once, daily Receives: Drug: AZD9056
6	Placebo comparator	oral, once daily 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) at 6 Months
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 6 months' treatment
Measured: 6 months

Secondary outcomes (4)

American College of Rheumatology 50 Response (ACR50) at 6 Months
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 6 months' treatment.
Measured: 6 months
American College of Rheumatology 70 Response (ACR70) at 6 Months
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 6 months' treatment
Measured: 6 months
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
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 6 months' 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 6 months
Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
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 6 months 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 6 months

Timeline

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

Aug 2007Mar 2009

First posted24 Aug 2007 (estimated)
Study startAug 2007
Study completionMar 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 385 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00520572
Sponsor's protocol ID: D1520C00001
Status last verified: Jan 2013
First submitted: 22 Aug 2007
Last updated: 4 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Keystone EC, Wang MM, Layton M, Hollis S, McInnes IB; D1520C00001 Study Team. Clinical evaluation of the efficacy of the P2X7 purinergic receptor antagonist AZD9056 on the signs and symptoms of rheumatoid arthritis in patients with active disease despite treatment with methotrexate or sulphasalazine. Ann Rheum Dis. 2012 Oct;71(10):1630-5. doi: 10.1136/annrheumdis-2011-143578.
PubMed 22966146

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

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine
ClinicalTrials.gov ID: NCT00520572
Acronym / sponsor ID: D1520C00001
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 385 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2007
Study completion: Mar 2009 (actual)
First posted: 24 Aug 2007 (estimated)
Results: Posted 4 Oct 2010

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: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
1	Active comparator	Drug: EtanerceptEtanercept 50mg, subcutaneous, once weekly
2	Experimental	Drug: AZD905650mg oral, once daily
3	Experimental	Drug: AZD9056100 mg oral, once daily
4	Experimental	Drug: AZD9056200 mg oral, once daily
5	Experimental	Drug: AZD9056400mg once, daily
6	Placebo comparator	Drug: Placebooral, once daily

Who may qualify

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

Key inclusion criteria (2 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 and current presence of positive rheumatoid factor (blood test), baseline radiographic erosion.
Be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate for at least 6 months prior to randomisation.

Key exclusion criteria (1 listed)

Any other inflammatory disease in addition to RA that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, e t c). Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. Persistently abnormal liver function enzymes (blood test).

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
AZD9056	Drug	2, 3, 4, 5
Etanercept	Drug	1
Placebo	Drug	6

Primary outcome

American College of Rheumatology 20 Response (ACR20) at 6 Months
Time frame: 6 months
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 6 months' treatment

4 secondary outcomes

American College of Rheumatology 50 Response (ACR50) at 6 Months
Time frame: 6 months
American College of Rheumatology 70 Response (ACR70) at 6 Months
Time frame: 6 months
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
Time frame: Baseline to 6 months
Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
Time frame: Baseline to 6 months

Results and safety

Results posted to the registry on 4 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD9056 50 mg	64	52
AZD9056 100 mg	64	50
AZD9056 200 mg	64	49
AZD9056 400 mg	64	50
Placebo	65	53
Etanercept	64	62

Primary outcome: American College of Rheumatology 20 Response (ACR20) at 6 Months

Time frame: 6 months. Number. Unit: Participants

Measure	AZD9056 50 mg n = 63	AZD9056 100 mg n = 64	AZD9056 200 mg n = 63	AZD9056 400 mg n = 64	Placebo n = 65	Etanercept n = 64
Value	23	26	23	21	21	42

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
AZD9056 50 mg	2 of 63 (3.2%)	17 of 63 (27%)	Not reported
AZD9056 100 mg	0 of 64 (0%)	24 of 64 (37.5%)	Not reported
AZD9056 200 mg	1 of 63 (1.6%)	20 of 63 (31.7%)	Not reported
AZD9056 400 mg	1 of 64 (1.6%)	29 of 64 (45.3%)	Not reported
Placebo	1 of 65 (1.5%)	20 of 65 (30.8%)	Not reported
Etanercept	2 of 64 (3.1%)	11 of 64 (17.2%)	Not reported

Limitations and caveats (from the sponsor): Hybrid ACR, ACRn, individual ACR components, Erythrocyte sedimentation rate, Short-form-36, Rheumatoid Arthritis Quality of Life, Patient Assessment of Fatigue and DEXA X-ray scanning 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 4 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22966146Keystone EC, Wang MM, Layton M, Hollis S, McInnes IB; D1520C00001 Study Team. Clinical evaluation of the efficacy of the P2X7 purinergic receptor antagonist AZD9056 on the signs and symptoms of rheumatoid arthritis in patients with active disease despite treatment with methotrexate or sulphasalazine. Ann Rheum Dis. 2012 Oct;71(10):1630-5. doi: 10.1136/annrheumdis-2011-143578.

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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.

Edward Keystone, MD, FRCPC principal investigator

MOUNT SINAI HOSPITAL

Zoltan Koroknai, MD, D.E.A.A. study chair

Omnicare Clinical Research

51 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD9056 and Etanercept in people with Rheumatoid Arthritis, run by AstraZeneca at 51 sites in 12 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 2 inclusion and 1 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Poland, United States, Mexico, Romania, Argentina and 7 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 4 Oct 2010). 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) at 6 Months (time frame: 6 months). 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 NCT00520572, 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 4 Feb 2013.