Takayasu's ArteritisPhase 2NCT00556439
Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis
A Phase 2 study testing Abatacept in people with Takayasu's Arteritis and Giant Cell Arteritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 10 sites in 2 countries.
Trial summary
Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the largest blood vessel in the body, and its branches. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Takayasu's Arteritis, Giant Cell Arteritis
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Dec 2008to Aug 2015
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of GCA or TAK (defined below)
- History of active GCA or TAK within the past 2 months
- Age of 15 years or older
- Willing to use an effective means of birth control throughout the study
- Specific Inclusion Criteria for Participants with GCA:
- Participants must meet three of the following five criteria, including either Criterion 4 or 5:
Show all 18Show fewer
- Age at disease onset was equal to or greater than 50 years
- Disease onset was recent or experiencing a new type of localized pain in the head
- Erythrocyte sedimentation rate greater than 40mm in the first hour, as determined using the Westergren method
- Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries)
- Temporal artery or large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cell or characteristic changes of large vessel stenosis or aneurysm by arteriography
- Specific Inclusion Criteria for Participants with TAK:
- Presence of abnormalities that are consistent with TAK identified using arteriography, plus at least one of the following criteria:
- Age at disease onset was less than 50 years
- Pain in the legs or arms
- Decreased brachial artery pulse (one or both arteries)
- Difference of more than 10mm Hg in blood pressure between the arms
- Bruit over subclavian arteries or aorta
Who cannot join
- Evidence of active infection (including chronic infection)
- Pregnant or breastfeeding
- HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen
- Inability to comply with study guidelines
- Inability to provide informed consent
- Cytopenia, as defined by a platelet count of less than 80,000/mm3, an absolute neutrophil count of less than 1,500/mm3, and hematocrit less than 20%
Show all 31Show fewer
- Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
- Other uncontrolled disease that could prevent safe study completion
- History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years
- Receipt of an investigational agent or device within 30 days prior to study entry
- A live vaccination within 4 weeks prior to study entry
- Presence of a positive tuberculin skin test with induration of at least 5mm
- Radiographic evidence suggestive of tuberculosis
- Poor tolerability of blood draws or lack of adequate access to veins for medication administration and blood draws
- History of treatment with rituximab within 12 months prior to study entry or history of treatment with rituximab more than 12 months prior to study entry, where the B lymphocyte count has not returned to normal
- History of treatment with infliximab within the past 49 days, adalimumab within the past 28 days, or etanercept within the past 21 days.
- Presence of any of the following diseases or conditions:
- Microscopic polyangiitis
- Churg-Strauss syndrome
- Polyarteritis nodosa
- Cogan's syndrome
- Behcet disease
- Sarcoidosis
- Kawasaki disease
- Tuberculosis or atypical mycobacterial infection
- Deep fungal infection
- Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis
- Cryoglobulinemic vasculitis
- Systemic lupus erythematosus
- Rheumatoid arthritis
- Mixed connective tissue disease or any overlap autoimmune syndrome
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Johns Hopkins Medical Center
Baltimore, Maryland, 21224
Boston University
Boston, Massachusetts, 02118
Cleveland Clinic
Cleveland, Ohio, 44195
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Hospital for Special Surgery
New York, New York, 10021
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84132
Canada2 sites
St. Joseph's Hospital
Hamilton, Ontario, L8P 3B3
Mt. Sinai Hospital Toronto
Toronto, Ontario, M5T 3L9
About this study
Official title: Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu's Arteritis to Examine the Safety, Efficacy, and Immunologic Effects of Abatacept (CTLA4-Ig) in Large Vessel Vasculitis
Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the largest blood vessel in the body, and its branches. Therapies are available to improve the symptoms of GCA and TAK, but relapse often occurs, and better treatments are needed. Abatacept is a drug that interacts with certain cells in the body that are involved with GCA and TAK. This study will evaluate the effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.
Read the detailed description
GCA and TAK both cause inflammation in the lining of the arteries, which can interfere with the body's ability to carry oxygen to areas that need it. Symptoms of GCA include headaches, jaw pain, and blurred or double vision. Serious symptoms that occur less commonly are blindness and stroke. TAK symptoms include fever, fatigue, weight loss, arthritis, and non-specific aches and pains. There may also be tenderness near affected arteries. Researchers believe that GCA and TAK are diseases that are controlled by the body's immune system. Activated T-cells, specifically, are critical to the origin and development of these diseases. Abatacept is a medication that modulates the signal required for T-cell activation. This study will evaluate the safety and effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.
Participation in this study may last up to 4 years. Participants will receive abatacept intravenously on specified days during Months 1, 2, and 3. They will also receive daily prednisone, which will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to either continue abatacept or be switched to placebo infusions. Both treatments will be given once a month at study visits. Blood samples will also be collected at the monthly study visits to conduct laboratory-based studies. Participants who remain in remission will continue to receive abatacept or placebo monthly until the common closing date, defined as 12 months after enrollment of the 33rd participant for each disease.
- Conditions
- Takayasu's Arteritis, Giant Cell Arteritis
- Being tested
- Abatacept, Placebo
- Keywords
- Vasculitis, Arteritis, Takayasu's, Temporal Arteritis, Abatacept
- Medical subject headings
- Takayasu Arteritis, Giant Cell Arteritis, Vasculitis, Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia
Participants will receive a fixed dose of abatacept, approximating 10mg per kilogram of body weight. The following dosing rules will be followed:
- Participants weighing less than 60kg will receive 500mg of abatacept.
- Participants weighing 60 to 100kg will receive 750mg of abatacept.
- Participants weighing more than 100kg will receive 1000mg of abatacept.
Abatacept will be administered in a 30-minute intravenous infusion on Days 1, 15, 29 (Month 1) and at Month 2. In the absence of toxicity or relapse, participants will remain on abatacept at the same dosage until randomization at Month 3. After randomization, only Group A (giant cell arteritis) and Group C (Takayasu arteritis) participants will continue on abatacept.
PlaceboDrug
Placebo abatacept infusions will be given monthly after random assignment at Month 3.
| Study group | Role | What they receive |
|---|---|---|
| A and C | Experimental | This is a randomized withdrawal design protocol. All participants will receive abatacept and prednisone (a glucocorticoid) for the first 3 months. Abatacept will be given intravenously on selected days. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A for giant cell arteritis and Group C for Takayasu arteritis. Receives: Drug: Abatacept |
| B and D | Placebo comparator | This is a randomized withdrawal design protocol. All participants will receive abatacept and prednisone (a glucocorticoid) for the first 3 months. Abatacept will be given intravenously on selected days. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B for giant cell arteritis and Group D for Takayasu arteritis. Receives: Drug: Abatacept; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome - Relapse-free Survival (RFS)
Relapse: presence of active disease occurring after a period of remission
Remission: absence of active disease
Active disease defined by clinical features or imaging or both:
Clinical features:
1 or more of the following attributed to GCA/TAK:
- Sustained fever of >38 C for > 1 week
- Vascular pain/tenderness > 1 day, non-fleeting
- Headache a) present > 1 day b) non-fleeting c) not relieved with analgesics d) not typical for pre-existing headaches
- Ischemic retinopathy, optic neuropathy, or visual loss
- Tongue/jaw pain and/or claudication
- TIA or stroke
- Extremity claudication
- Musculoskeletal symptoms + ESR of > 40 mm/hr or CRP above the normal limit
- Malaise/fatigue + ESR of > 40 mm/hr or CRP above the normal limit
- Other symptoms/signs due to GCA/TAK requiring reinstitution/increase in GC
Imaging features
- Development of new vascular stenosis or aneurysm in new vascular territories as seen by MRI/MRA or arteriogram
Measured: Weeks 0 to 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startDec 2008
- Primary completionAug 2015
- Study completionAug 2015
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 (3)Papers the sponsor has linked to this study.
- Other trials for Takayasu's ArteritisStudies of the same condition, open and under way.
- 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Cleveland Clinic, Office of Rare Diseases (ORD), Rare Diseases Clinical Research Network
- Responsible party
- Sponsor
- Investigators
- Carol A. Langford, MD, MHS, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556439
- Sponsor's protocol ID
- N01 AR070018
- Other IDs
- 268200700036C-5-0-1, HHSN2682007000036C
- Status last verified
- Jan 2018
- First submitted
- 9 Nov 2007
- Last updated
- 26 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Langford CA, Cuthbertson D, Ytterberg SR, Khalidi N, Monach PA, Carette S, Seo P, Moreland LW, Weisman M, Koening CL, Sreih AG, Spiera R, McAlear CA, Warrington KJ, Pagnoux C, McKinnon K, Forbess LJ, Hoffman GS, Borchin R, Krischer JP, Merkel PA; Vasculitis Clinical Research Consortium. A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Takayasu Arteritis. Arthritis Rheumatol. 2017 Apr;69(4):846-853. doi: 10.1002/art.40037. Epub 2017 Mar 8.
PubMed 28133931Langford CA, Cuthbertson D, Ytterberg SR, Khalidi N, Monach PA, Carette S, Seo P, Moreland LW, Weisman M, Koening CL, Sreih AG, Spiera R, McAlear CA, Warrington KJ, Pagnoux C, McKinnon K, Forbess LJ, Hoffman GS, Borchin R, Krischer JP, Merkel PA; Vasculitis Clinical Research Consortium. A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Giant Cell Arteritis. Arthritis Rheumatol. 2017 Apr;69(4):837-845. doi: 10.1002/art.40044. Epub 2017 Mar 3.
PubMed 28133925Goldstein BL, Gedmintas L, Todd DJ. Drug-associated polymyalgia rheumatica/giant cell arteritis occurring in two patients after treatment with ipilimumab, an antagonist of ctla-4. Arthritis Rheumatol. 2014 Mar;66(3):768-9. doi: 10.1002/art.38282. No abstract available.
PubMed 24574239
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Pilot Studies in Giant Cell Arteritis and Takayasu's Arteritis to Examine the Safety, Efficacy, and Immunologic Effects of Abatacept (CTLA4-Ig) in Large Vessel Vasculitis
- ClinicalTrials.gov ID
- NCT00556439
- Acronym / sponsor ID
- N01 AR070018
- Conditions
- Takayasu's Arteritis, Giant Cell Arteritis
- Keywords
- Vasculitis, Arteritis, Takayasu's, Temporal Arteritis, Abatacept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Collaborators
- The Cleveland Clinic, Office of Rare Diseases (ORD), Rare Diseases Clinical Research Network
- Study start
- Dec 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 26 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the largest blood vessel in the body, and its branches. Therapies are available to improve the symptoms of GCA and TAK, but relapse often occurs, and better treatments are needed. Abatacept is a drug that interacts with certain cells in the body that are involved with GCA and TAK. This study will evaluate the effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.
Detailed description
GCA and TAK both cause inflammation in the lining of the arteries, which can interfere with the body's ability to carry oxygen to areas that need it. Symptoms of GCA include headaches, jaw pain, and blurred or double vision. Serious symptoms that occur less commonly are blindness and stroke. TAK symptoms include fever, fatigue, weight loss, arthritis, and non-specific aches and pains. There may also be tenderness near affected arteries. Researchers believe that GCA and TAK are diseases that are controlled by the body's immune system. Activated T-cells, specifically, are critical to the origin and development of these diseases. Abatacept is a medication that modulates the signal required for T-cell activation. This study will evaluate the safety and effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.
Participation in this study may last up to 4 years. Participants will receive abatacept intravenously on specified days during Months 1, 2, and 3. They will also receive daily prednisone, which will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to either continue abatacept or be switched to placebo infusions. Both treatments will be given once a month at study visits. Blood samples will also be collected at the monthly study visits to conduct laboratory-based studies. Participants who remain in remission will continue to receive abatacept or placebo monthly until the common closing date, defined as 12 months after enrollment of the 33rd participant for each disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A and C | Experimental | Drug: AbataceptThis is a randomized withdrawal design protocol. All participants will receive abatacept and prednisone (a glucocorticoid) for the first 3 months. Abatacept will be given intravenously on selected days. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A for giant cell arteritis and Group C for Takayasu arteritis. |
| B and D | Placebo comparator | Drug: Abatacept, Drug: PlaceboThis is a randomized withdrawal design protocol. All participants will receive abatacept and prednisone (a glucocorticoid) for the first 3 months. Abatacept will be given intravenously on selected days. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B for giant cell arteritis and Group D for Takayasu arteritis. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of GCA or TAK (defined below)
- History of active GCA or TAK within the past 2 months
- Age of 15 years or older
- Willing to use an effective means of birth control throughout the study
- Participants must meet three of the following five criteria, including either Criterion 4 or 5:
Key exclusion criteria (31 listed)
- Evidence of active infection (including chronic infection)
- Pregnant or breastfeeding
- HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen
- Inability to comply with study guidelines
- Inability to provide informed consent
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 |
|---|---|---|
| AbataceptAlso: OrenciaParticipants will receive a fixed dose of abatacept, approximating 10mg per kilogram of body weight. The following dosing rules will be followed: * Participants weighing less than 60kg will receive 500mg of abatacept. * Participants weighing 60 to 100kg will receive 750mg of abatacept. * Participants weighing more than 100kg will receive 1000mg of abatacept. Abatacept will be administered in a 30-minute intravenous infusion on Days 1, 15, 29 (Month 1) and at Month 2. In the absence of toxicity or relapse, participants will remain on abatacept at the same dosage until randomization at Month 3. After randomization, only Group A (giant cell arteritis) and Group C (Takayasu arteritis) participants will continue on abatacept. | Drug | A and C, B and D |
| PlaceboPlacebo abatacept infusions will be given monthly after random assignment at Month 3. | Drug | B and D |
Primary outcome
Primary Outcome - Relapse-free Survival (RFS)
Time frame: Weeks 0 to 64
Relapse: presence of active disease occurring after a period of remission Remission: absence of active disease Active disease defined by clinical features or imaging or both: Clinical features: 1 or more of the following attributed to GCA/TAK: * Sustained fever of >38 C for > 1 week * Vascular pain/tenderness > 1 day, non-fleeting * Headache a) present > 1 day b) non-fleeting c) not relieved with analgesics d) not typical for pre-existing headaches * Ischemic retinopathy, optic neuropathy, or visual loss * Tongue/jaw pain and/or claudication * TIA or stroke * Extremity claudication * Musculoskeletal symptoms + ESR of > 40 mm/hr or CRP above the normal limit * Malaise/fatigue + ESR of > 40 mm/hr or CRP above the normal limit * Other symptoms/signs due to GCA/TAK requiring reinstitution/increase in GC Imaging features • Development of new vascular stenosis or aneurysm in new vascular territories as seen by MRI/MRA or arteriogram
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28133931Langford CA, Cuthbertson D, Ytterberg SR, Khalidi N, Monach PA, Carette S, Seo P, Moreland LW, Weisman M, Koening CL, Sreih AG, Spiera R, McAlear CA, Warrington KJ, Pagnoux C, McKinnon K, Forbess LJ, Hoffman GS, Borchin R, Krischer JP, Merkel PA; Vasculitis Clinical Research Consortium. A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Takayasu Arteritis. Arthritis Rheumatol. 2017 Apr;69(4):846-853. doi: 10.1002/art.40037. Epub 2017 Mar 8.
- Derived from this study: PubMed 28133925Langford CA, Cuthbertson D, Ytterberg SR, Khalidi N, Monach PA, Carette S, Seo P, Moreland LW, Weisman M, Koening CL, Sreih AG, Spiera R, McAlear CA, Warrington KJ, Pagnoux C, McKinnon K, Forbess LJ, Hoffman GS, Borchin R, Krischer JP, Merkel PA; Vasculitis Clinical Research Consortium. A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Giant Cell Arteritis. Arthritis Rheumatol. 2017 Apr;69(4):837-845. doi: 10.1002/art.40044. Epub 2017 Mar 3.
- Derived from this study: PubMed 24574239Goldstein BL, Gedmintas L, Todd DJ. Drug-associated polymyalgia rheumatica/giant cell arteritis occurring in two patients after treatment with ipilimumab, an antagonist of ctla-4. Arthritis Rheumatol. 2014 Mar;66(3):768-9. doi: 10.1002/art.38282. No abstract available.
- Click here for the Cleveland Clinic Center for Vasculitis Care and Research Web siteLink provided by the sponsor.
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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.
Carol A. Langford, MD, MHS principal investigator
The Cleveland Clinic
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abatacept in people with Takayasu's Arteritis and Giant Cell Arteritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 10 sites in 2 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 18 inclusion and 31 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 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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 26 Feb 2018). 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?
Primary Outcome - Relapse-free Survival (RFS) (time frame: Weeks 0 to 64). 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 NCT00556439, which also lists 3 linked publications.
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 26 Feb 2018.