Relapsing PolychondritisPhase 1NCT01272856
Study on the Safety of Abatacept in Relapsing Polychondritis
A Phase 1 study testing Abatacept in people with Relapsing Polychondritis, run by Benaroya Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to test the safety of the study drug abatacept and see what effects (good and bad) it has in patients with relapsing polychondritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Relapsing Polychondritis
- What is being tested?
- Abatacept
- 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
- Jan 2011to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Written Informed Consent
- Diagnosed with relapsing consisting of 2 major or 1 major + 2 minor criteria as follows:
- Major criteria
- Proven inflammatory episodes involving auricular cartilage
- Proven inflammatory episodes involving nasal cartilage
- Proven inflammatory episodes involving laryngotracheal cartilage
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- Minor criteria
- Ocular inflammation (conjunctivitis, keratitis, episcleritis, uveitis)
- Hearing loss
- Vestibular dysfunction
- Seronegative inflammatory arthritis
- Active RPC based on at least one of the following:
- Active chondritis as defined as active inflammation, as observed by the Investigator, in auricular and/or nasal cartilage
- Active tracheal and/or pulmonary disease documented by abnormal spirometry or chest computed tomography
- Erythrocyte sedimentation rate ≥ 30 mm/hr or C-reactive protein ≥ 0.6 mg/dL
- If receiving any of the following medications, has been on a stable dose for the durations indicated without intent to change throughout the study:
- Azathioprine, methotrexate, mycophenolate, leflunomide: 1 month
- Corticosteroids: 2 weeks
- Nonsteroidal anti-inflammatory drugs (NSAIDs): 1 week
- Age and Sex
- Men and women, greater than 18 years of age
- Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of study drug to minimize the risk of pregnancy.
- Women of child bearing age include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
- Amenorrhea that has lasted for greater than 12 consecutive months without another cause, or
- For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
- Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
- Women of child bearing age must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of the investigational product.
- A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 10 weeks after the last dose of study drug to minimize the risk of pregnancy.
Who cannot join
- Sex and Reproductive Status
- Women of child bearing age who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study drug.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or before administration of abatacept.
- Target Disease Exceptions
- Fulfills American College of Rheumatology criteria for any other connective tissue disease, such as but not necessarily limited to systemic lupus erythematosus, systemic sclerosis (scleroderma), polymyositis or dermatomyositis, or rheumatoid arthritis, or possesses another distinct condition known to be associated with chondritis, such as Wegener's granulomatosis or Behcet's disease
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- Use of cyclophosphamide, cyclosporine A or tacrolimus within one month or at any time during administration of study drug
- Use of biologic treatments within the timeframes indicated:
- Anti-CD20 monoclonal antibodies or other immune cell-depleting therapy in the last 6 months or without evidence of appropriate lineage reconstitution
- TNF antagonists, IL-1R antagonists, or co-stimulation modulators in the last 3 months
- Any prior treatment with stem cell transplantation or other myeloablative therapy
- Concomitant illness or disease activity which, in the opinion of the investigator, is likely to require significant additional immunosuppressive therapy (e.g. > 40 mg daily oral prednisone for asthma) during the course of the study
- Medical History and Concurrent Diseases
- Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
- Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to RPC and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- Female subjects who have had a breast cancer screening that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded by additional clinical, laboratory, or other diagnostic evaluations.
- Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ. Existing non-melanoma skin cell cancers should be removed, the lesion site healed, and residual cancer ruled out before administration of the study drug.
- Subjects who currently abuse drugs or alcohol.
- Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of human immunodeficiency virus (HIV) detected during screening.
- Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before the informed consent document was signed.
- Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication.
- Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (eg, chronic pyelonephritis, osteomyelitis, or bronchiectasis).
- Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be subjects with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
- Physical and Laboratory Test Findings
- Subjects must not be positive for hepatitis B surface antigen.
- Subjects who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.
- Subjects with any of the following laboratory values
- Hemoglobin < 8.5 g/dL
- WBC < 3000/mm3 (< 3 x 109/L)
- Platelets < 100,000/mm3 (< 3 x 109/L)
- Serum creatinine > 2 times the ULN
- Serum ALT or AST > 2 times the ULN
- Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- Allergies and Adverse Drug Reactions
- Known sensitivity to abatacept
- Prohibited Treatments and/or Therapies
- Subjects who have at any time received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1 dose.
- Any concomitant biologic DMARD, such as anakinra.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: An Open-Label, Single-Center, Phase I Study on the Safety of Abatacept in Relapsing Polychondritis
The purpose of this study is to test the safety of the study drug abatacept and see what effects (good and bad) it has in patients with relapsing polychondritis.
Read the detailed description
After a screening period of up to 4 weeks, patients who fulfill all inclusion and exclusion criteria will receive open-label subcutaneous abatacept consisting of 125 mg weekly, beginning 1 week thru Week 24.
Throughout the study, blood will be collected for clinical laboratory safety, pharmacodynamics and biomarkers. Disease activity assessments will include laboratory evaluation of acute phase reactants, pulmonary function testing, computed tomography of the neck and chest, electrocardiogram, echocardiogram, audiogram, physician assessment of chondritis activity, swollen and tender joint counts, and patient- and physican-reported outcomes. Adverse events and concomitant medications will be recorded.
- Conditions
- Relapsing Polychondritis
- Being tested
- Abatacept
- Medical subject headings
- Polychondritis, Relapsing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia
125 mg pre-filled syringe for sub-q injection weekly.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Abatacept | Experimental | Not described Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: 24 Weeks
Secondary outcomes (3)
Physician assessment of chondritis burden
Measured: 24 Weeks
Acute phase reactants (ESR, CRP)
Measured: 24 weeks
Patient and physician-reported outcome measures, including HAQ, SF-36, and Visual Analogue Scores
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing PolychondritisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Stanford Peng, Benaroya Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272856
- Sponsor's protocol ID
- IRB10063
- Status last verified
- Aug 2012
- First submitted
- 6 Jan 2011
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Peng SL, Rodriguez D. Abatacept in relapsing polychondritis. Ann Rheum Dis. 2013 Aug;72(8):1427-9. doi: 10.1136/annrheumdis-2013-203319. Epub 2013 Apr 20. No abstract available.
PubMed 23606702
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Center, Phase I Study on the Safety of Abatacept in Relapsing Polychondritis
- ClinicalTrials.gov ID
- NCT01272856
- Acronym / sponsor ID
- IRB10063
- Conditions
- Relapsing Polychondritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
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 study is to test the safety of the study drug abatacept and see what effects (good and bad) it has in patients with relapsing polychondritis.
Detailed description
After a screening period of up to 4 weeks, patients who fulfill all inclusion and exclusion criteria will receive open-label subcutaneous abatacept consisting of 125 mg weekly, beginning 1 week thru Week 24.
Throughout the study, blood will be collected for clinical laboratory safety, pharmacodynamics and biomarkers. Disease activity assessments will include laboratory evaluation of acute phase reactants, pulmonary function testing, computed tomography of the neck and chest, electrocardiogram, echocardiogram, audiogram, physician assessment of chondritis activity, swollen and tender joint counts, and patient- and physican-reported outcomes. Adverse events and concomitant medications will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Abatacept | Experimental | Drug: Abatacept |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Signed Written Informed Consent
- Diagnosed with relapsing consisting of 2 major or 1 major + 2 minor criteria as follows:
- Age and Sex
- Women of child bearing age include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
- Amenorrhea that has lasted for greater than 12 consecutive months without another cause, or
Key exclusion criteria (38 listed)
- Sex and Reproductive Status
- Target Disease Exceptions
- Medical History and Concurrent Diseases
- Physical and Laboratory Test Findings
- Allergies and Adverse Drug Reactions
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: Orencia125 mg pre-filled syringe for sub-q injection weekly. | Drug | Open Label Abatacept |
Primary outcome
Incidence of adverse events
Time frame: 24 Weeks
3 secondary outcomes
Physician assessment of chondritis burden
Time frame: 24 Weeks
Acute phase reactants (ESR, CRP)
Time frame: 24 weeks
Patient and physician-reported outcome measures, including HAQ, SF-36, and Visual Analogue Scores
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Derived from this study: PubMed 23606702Peng SL, Rodriguez D. Abatacept in relapsing polychondritis. Ann Rheum Dis. 2013 Aug;72(8):1427-9. doi: 10.1136/annrheumdis-2013-203319. Epub 2013 Apr 20. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abatacept in people with Relapsing Polychondritis, run by Benaroya Research Institute 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 28 inclusion and 38 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 7 Aug 2012. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of adverse events (time frame: 24 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 NCT01272856, 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 7 Aug 2012.