Rheumatoid ArthritisPhase 2NCT00805467

Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies

A Phase 2 study testing Fostamatinib Disodium (R935788) in people with Rheumatoid Arthritis, run by AstraZeneca at 76 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time. 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?: Fostamatinib Disodium (R935788)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 624 participants
Where: 76 sitesin 11 countries
Study dates: Aug 2008to Aug 2013
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

Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study
Patients who are being treated in Study C-788-006X
Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events
Patients who withdrew from Study C-788-010 at Month 4 or Month 5 because of a pre-defined lack of efficacy
Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative pregnancy test at the time of entry and at each laboratory determination.

Who cannot join

The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
unresolved Grade 2 or greater toxicity in a RA protocol studying R788
uncontrolled or poorly controlled hypertension;
recent (within past 2 months) serious surgery or infectious disease;
recent history (since enrollment in prior R788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;
known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;

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interstitial pneumonitis or active pulmonary infection;
known laboratory abnormalities: ALT > 1.2 x ULN, creatinine >1.5x ULN, an ANC <2,500/mm3 or 2.5 x 109/L, lymphocyte count < 600/mm3 or 0.6 x 109L, Hgb < 9 g/dL or 5 mmol/L, platelet count <125,000/mm3 or 125 x 109/L are excluded.
The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine = 3 oz or 89 mL; 80 proof distilled spirits = 1.5 oz or 44 mL.
The patient is unable to report for clinical and laboratory monitoring as per protocol.

Trial locations and contacts

76 sites in 11 countries.

Country

City, postcode or hospital

76 sites in 11 countries

United States35 sites

Research Site
Austin, Texas
Research Site
Aventura, Florida
Research Site
Boca Raton, Florida
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Boise, Idaho
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Coeur d'Alene, Idaho
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Cumberland, Maryland
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Elizabethtown, Kentucky
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Erie, Pennsylvania
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Gainesville, Florida
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Hagerstown, Maryland
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Hamden, Connecticut
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Jackson, Tennessee
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La Jolla, California
Research Site
Lansing, Michigan
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Mayfiled Village, Ohio
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Ocala, Florida
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Oklahoma City, Washington
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Omaha, Nebraska
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Orange Park, Florida
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Orlando, Florida
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Palm Desert, California
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Palo Alto, California
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Raleigh, North Carolina
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Roslyn, New York
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San Antonio, Texas
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San Diego, California
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Santa Maria, California
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Smithtown, New York
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South Bend, Indiana
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South Miami, Florida
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Spokane, Washington
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Venice, Florida
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Washington D.C., District of Columbia
Research Site
Willow Grove, Pennsylvania
Research Site
Wyomissing, Pennsylvania

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Mexico9 sites

Research Site
Chihuahua City
Research Site
Cuernava
Research Site
Del. Cuauhtemoc
Research Site
Guadalajara
Research Site
León
Research Site
Mexcio
Research Site
México
Research Site
Morelia
Research Site
San Luis Potosí City

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Poland9 sites

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Bialystok
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Bytom
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Elblag
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Grodzisk Mazowiecki
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Krakow
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Lublin
Research Site
Torun
Research Site
Wroclaw
Research Site
Zyrardów

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Romania5 sites

Research Site
Brailari
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Sf. Gheorghe
Research Site
Sibiu

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Colombia4 sites

Research Site
Barranquilla
Research Site
Bogotá
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Bucaramanga
Research Site
Medellín

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Belgium3 sites

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Antwerp
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Ghent
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Liège

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Bulgaria3 sites

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Plovdiv
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Rousse
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Sofia

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Germany3 sites

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Hamburg
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Leipzig
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Würzburg

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Italy2 sites

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Siena
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Udine

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Peru2 sites

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Jesus Maria
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Lima

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France1 site

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Bordeaux

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About this study

Official title: An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.

Conditions: Rheumatoid Arthritis
Being tested: Fostamatinib Disodium (R935788)
Keywords: RA
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

Fostamatinib Disodium (R935788)Drug
Also called R935788
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD

Study groups in NCT00805467
Study group	Role	What they receive
1	Experimental	R935788 50 mg tablet, orally, twice-a-day Receives: Drug: Fostamatinib Disodium (R935788)
2	Experimental	R935788 100 mg tablet, orally, twice-a-day Receives: Drug: Fostamatinib Disodium (R935788)
3	Experimental	R935788 100 mg tablet, orally, once-a-day Receives: Drug: Fostamatinib Disodium (R935788)
4	Experimental	R935788 150 mg tablet, orally, once-a-day Receives: Drug: Fostamatinib Disodium (R935788)

What is being measured

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

Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Measured: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)

Secondary outcomes (2)

DAS28-CRP Score
The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily
Measured: 3 years
HAQ-DI Score
Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.
Measured: 3 years

Timeline

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

Aug 2008Aug 2013

First posted9 Dec 2008 (estimated)
Study startAug 2008
Primary completionAug 2013
Study completionAug 2013

Why it stopped: AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.

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.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 624 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00805467
Sponsor's protocol ID: C-935788-012
Other IDs: D4300C00021
Status last verified: May 2014
First submitted: 5 Dec 2008
Last updated: 25 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study
ClinicalTrials.gov ID: NCT00805467
Acronym / sponsor ID: C-935788-012
Conditions: Rheumatoid Arthritis
Keywords: RA
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.
Enrolment: 624 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 9 Dec 2008 (estimated)
Results: Posted 25 Jun 2014

Clinical summary

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

The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: Fostamatinib Disodium (R935788)R935788 50 mg tablet, orally, twice-a-day
2	Experimental	Drug: Fostamatinib Disodium (R935788)R935788 100 mg tablet, orally, twice-a-day
3	Experimental	Drug: Fostamatinib Disodium (R935788)R935788 100 mg tablet, orally, once-a-day
4	Experimental	Drug: Fostamatinib Disodium (R935788)R935788 150 mg tablet, orally, once-a-day

Who may qualify

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

Key inclusion criteria (5 listed)

Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study
Patients who are being treated in Study C-788-006X
Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events
Patients who withdrew from Study C-788-010 at Month 4 or Month 5 because of a pre-defined lack of efficacy
Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative pregnancy test at the time of entry and at each laboratory determination.

Key exclusion criteria (10 listed)

The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine = 3 oz or 89 mL; 80 proof distilled spirits = 1.5 oz or 44 mL.
The patient is unable to report for clinical and laboratory monitoring as per protocol.

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
Fostamatinib Disodium (R935788)Also: R93578850 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD	Drug	1, 2, 3, 4

Primary outcome

Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
Time frame: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event

2 secondary outcomes

DAS28-CRP Score
Time frame: 3 years
HAQ-DI Score
Time frame: 3 years

Results and safety

Results posted to the registry on 25 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fostamatinib 50 mg Bid	1	1
Fostamatinib 100 mg qd	59	25
Fostamatinib 150 mg qd	183	80
Fostamatinib 100 mg Bid	381	144

Primary outcome: Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category

Time frame: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years). Number. Unit: % of patients

Measure	Fostamatinib 50 mg Bid n = 1	Fostamatinib 100 mg qd n = 59	Fostamatinib 150 mg qd n = 183	Fostamatinib 100 mg Bid n = 381
Any AE	100	91.5	90.7	88.7
Any fatal AE	0	1.7	3.8	1.6
Any SAE (including fatal AEs)	100	3.4	18.6	20.2
Any AE leading to termination of study therapy	0	22.0	16.4	15.2

Population analysed: The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).

2 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
100 MG BID	77 of 381 (20.2%)	306 of 381 (80.3%)	Not reported
100 MG QD	2 of 59 (3.4%)	49 of 59 (83.1%)	Not reported
150 MG QD	34 of 183 (18.6%)	141 of 183 (77%)	Not reported
50 MG BID	1 of 1 (100%)	1 of 1 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

Active, not recruitingPhase 1
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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.

Chris O'Brien, MD, PhD study director

AstraZeneca

76 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fostamatinib Disodium (R935788) in people with Rheumatoid Arthritis, run by AstraZeneca at 76 sites in 11 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Mexico, Poland, Romania, Colombia and 6 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. 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 25 Jun 2014). 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?

Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category (time frame: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)). 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 NCT00805467.

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 25 Jun 2014.