UrticariaPhase 1/2TAHOENCT00886795
Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy
A Phase 1/2 study testing abatacept (Orencia ®) in people with Urticaria, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urticaria
- What is being tested?
- abatacept (Orencia ®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Mar 2013
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic active urticaria defined as symptoms > 50% of days or 3 days/week for more than 12 weeks
- Chronic therapy with stable doses of antihistamines for at least 4 weeks (patients may be taking more than one antihistamine or be taking combinations of antihistamines and leukotriene receptor antagonists) AND failure to respond to at least maximally approved dosages of 2 different antihistamine therapies
- One of the following 3 conditions:
- Previous or ongoing requirement for corticosteroids for symptom control OR
- Prior steroid treatment with steroid discontinuation due to unacceptable morbidity
- Previous or current use (without symptom control or with unacceptable morbidity: e.g., hypertension from cyclosporine, hemolysis from dapsone) of immunomodulatory treatment for urticaria (e.g., hydroxychloroquine, methotrexate, sulfasalazine, dapsone, cyclosporine, intravenous immunoglobulin (IVIg), mycophenolate, azathioprine, etc)
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- High baseline score for pruritis (at least 2 on a 3 point scale)
- No underlying etiology clearly defined for urticaria
- Patients should exhibit evidence of underlying autoimmunity of at least one of the following:
- elevated erythrocyte sedimentation rate (ESR), C-Reactive Protein (CRP), anti-nuclear antibody (ANA)
- extractable nuclear antigens
- Thyroid antibodies
- other autoantibodies (e.g., intrinsic factor, parietal cell, ovarian), *elevated complement levels
- clinical characteristics suggestive of systemic autoimmune disease but without satisfying criteria for another diagnosis (e.g., arthralgias, myalgias, arthritis, low grade fever, significant fatigue associated with outbreaks)
- family history of autoimmune disease including thyroid autoimmunity
- a biopsy showing perivascular lymphocytic or mixed cellular infiltrate without vasculitis
- Concomitant use of hydroxychloroquine, methotrexate, or sulfasalazine will be permitted if dose stable for at least 8 weeks
- Concomitant use of steroids (≤ 15 mg/d Prednisone or equivalent) will be permitted if stable for 4 weeks and patient agrees to continue dose for the first 90 days
- Negative pregnancy test (for women of child-bearing age)
- Men and women of reproductive potential must agree to use an acceptable birth control during treatment and for 3 months after treatment
- No planned elective surgical procedures for at least 6 months from day#1
Who cannot join
- Current use of other immunosuppressive medications (cyclosporine, tacrolimus, sirolimus, IVIg, cyclophosphamide, mycophenolate mofetil, azathioprine). Any such medication will be discontinued for at least 4 weeks before study drug start.
- Concomitant treatment with corticosteroids (≤ 15 mg/d), hydroxychloroquine, methotrexate, and sulfasalazine will be permitted if doses are stable at least 8 weeks
- Treatment with an investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
- Receipt of a live vaccine within 4 weeks of randomization
- Prior treatment with Abatacept (Orencia®)
- Previous treatment with Rituximab (MabThera®/Rituxan®), unless 6 months after administration AND B cell reconstitution has occurred into normal range
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- History of severe allergic or anaphylactic reactions to monoclonal antibodies or Fc fusion proteins
- History of significant laryngeal edema, tongue swelling, or airway compromise in the setting of urticarial/angioedema episode (isolated perioral, lip, and periorbital edema will not be exclusionary)
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis B and/or Hepatitis C
- purified protein derivative (PPD) testing as part of screening that is positive*
- HIV, Hepatitis B surface antigen or Core Antibody positive, or anti Hepatitis C Antibody positive detected with screening
- History of recurrent significant infection, active bacterial, viral, fungal, mycobacterial, or other infection excluding fungal infections of nail beds, or major infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 wks of screening
- Known immunodeficiency, hypogammaglobulinemia, etc.
- Systemic lupus erythematosus (meeting American College of Rheumatology (ACR)) criteria; patients with autoantibodies such as ANA will NOT be excluded)
- Lack of peripheral venous access
- Drug, alcohol, or chemical abuse within 6 months
- Pregnancy or lactation and all women must be willing to practice contraception through the study duration and for 3 months after discontinuing abatacept treatment.
- Sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.
- Prior to study enrollment, women of childbearing potential (WOCBP) will be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- In addition, men enrolled on this study will be informed of the risks to any sexual partner of childbearing potential and counseled to practice an effective method of birth control.
- All WOCBP must have a negative urine pregnancy test within 7 days prior to first receiving the investigational product.
- If the pregnancy test is positive, the subject will be excluded from the study.
- In addition, all WOCBP will be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation and the Investigator will notify Bristol Myers Squibb (BMS) within 24 hours of becoming aware of a confirmed pregnancy in a subject participating in the study.
- Women must agree to practice adequate birth control for a minimum of 3 months post-treatment.
- Concomitant malignancies or previous malignancies within five years, with exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix
- Atopic dermatitis, psoriasis, or autoimmune bullous skin disease (pemphigus, pemphigoid, etc)
- Significant cardiovascular disease (angina, arrhythmia, known coronary artery disease, cerebrovascular accident (CVA), transient ischemic attack (TIA), uncontrolled hypertension > 150/90)
- Significant pulmonary disease (asthma or chronic obstructive pulmonary disease (COPD) requiring current use of corticosteroids, history ever of severe asthma or status asthmatics)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates an investigational drug or that may affect interpretation of the results or render patient at high risk from treatment complications
- Plans or need to receive live viral vaccination over course of the study (e.g., Flu-Mist)
- Inability to comply with study and follow-up procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Arthritis Center
Baltimore, Maryland, 21224
About this study
Official title: A Phase I/II Open-label Study to Evaluate The Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy.
This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives).
- Conditions
- Urticaria
- Being tested
- abatacept (Orencia ®)
- Keywords
- hives, rash, pruritis
- Medical subject headings
- Urticaria, Exanthema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abatacept (Orencia ®)Drug
Also called orencia
4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Abatacept | Experimental | 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks. Receives: Drug: abatacept (Orencia ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.
Measured: baseline, 3 month and 6 months
Secondary outcomes (1)
Number of Participants With Clinically Detectable Improvement
Evaluations will occur at each visit after the first infusion. At 3 months, response will be recorded and patients with improvement will be eligible to move into the steroid and/or antihistamine tapering portion of the study. Improvement was determined by a reduction in the number of hives.
Measured: at each visit and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2013
- Study completionMar 2013
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 UrticariaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Clifton O Bingham, Johns Hopkins University
- Investigators
- Clifton O. Bingham, M.D., Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886795
- Sponsor's protocol ID
- Tahoe-001
- Acronym
- TAHOE
- Status last verified
- Dec 2015
- First submitted
- 22 Apr 2009
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-label Study to Evaluate The Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy.
- ClinicalTrials.gov ID
- NCT00886795
- Acronym / sponsor ID
- TAHOE / Tahoe-001
- Conditions
- Urticaria
- Keywords
- hives, rash, pruritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 25 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Drug: abatacept (Orencia ®)4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Chronic active urticaria defined as symptoms > 50% of days or 3 days/week for more than 12 weeks
- Chronic therapy with stable doses of antihistamines for at least 4 weeks (patients may be taking more than one antihistamine or be taking combinations of antihistamines and leukotriene receptor antagonists) AND failure to respond to at least maximally approved dosages of 2 different antihistamine therapies
- One of the following 3 conditions:
- High baseline score for pruritis (at least 2 on a 3 point scale)
- No underlying etiology clearly defined for urticaria
Key exclusion criteria (31 listed)
- Current use of other immunosuppressive medications (cyclosporine, tacrolimus, sirolimus, IVIg, cyclophosphamide, mycophenolate mofetil, azathioprine). Any such medication will be discontinued for at least 4 weeks before study drug start.
- Concomitant treatment with corticosteroids (≤ 15 mg/d), hydroxychloroquine, methotrexate, and sulfasalazine will be permitted if doses are stable at least 8 weeks
- Treatment with an investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
- Receipt of a live vaccine within 4 weeks of randomization
- Prior treatment with Abatacept (Orencia®)
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 |
|---|---|---|
| abatacept (Orencia ®)Also: orencia4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks. | Drug | Abatacept |
Primary outcome
Number of Participants With Adverse Events
Time frame: baseline, 3 month and 6 months
Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.
1 secondary outcome
Number of Participants With Clinically Detectable Improvement
Time frame: at each visit and at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clifton O. Bingham, M.D. principal investigator
Associate Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing abatacept (Orencia ®) in people with Urticaria, run by Johns Hopkins University at 1 site in United States.
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 21 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 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jan 2016). 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?
Number of Participants With Adverse Events (time frame: baseline, 3 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2016.