Rheumatoid ArthritisPhase 4NCT01009879
Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow Emigrants
A Phase 4 study testing Etanercept in people with Rheumatoid Arthritis, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of the study is to determine the effects of TNF (tumor necrosis factor; a mediator of inflammation) on B cells in patients with rheumatoid arthritis. TNF and B cells are important in rheumatoid arthritis because they both appear to be involved in causing rheumatoid arthritis. 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?
- Etanercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Feb 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis (RA) patients will be eligible for the study if they meet ACR criteria for a diagnosis of RA (Arnett et al. 1988. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis \& Rheumatism 31:315.) and have active disease (≥ 6 tender and/or swollen joints).
- Subjects must be ≥ 18 years of age.
- Subjects must be rheumatoid factor (RF) positive (any RF titer greater than the upper limits of normal) and/or anti-CCP antibody positive (any anti-CCP titer greater than the upper limits of normal). Subjects must have a negative TB skin test at entry into the study or a negative screening chest x-ray if the PPD test is inconclusive (borderline, reactive but non-diagnostic) or in prior BCG inoculated subjects. Female subjects of child bearing potential (excludes those that are surgically sterile or at least 5 years postmenopausal) must have a negative pregnancy test (serum β-HCG). Sexually active subjects of childbearing potential must agree to use medically acceptable forms of contraception during screening and throughout the study.
- Subjects or a designee must have the ability to self-inject ENBREL or a care-giver at home who can administer subcutaneous injections. Subjects must be willing to remain on ENBREL (50 mg SQ qweek) for at least 12 weeks and have not taken anti-rheumatic agents (DMARDS and/or corticosteroids) besides NSAIDs for the previous 4 weeks.
- The subject must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information. Before any study-specific procedure, the appropriate written informed consent must be obtained.
Who cannot join
- RA patients will be excluded if they have a history of congestive heart failure, recurrent or active infection, a positive PPD, history of neurologic disease, Felty's syndrome, hematologic malignancy or liver disease.
- RA patients will be excluded if they have a WBC count < 4.0, Hct < 30 or liver profile abnormalities (> 2x normal values of AST, ALT, TBili and/or APhos).
- RA patients will be excluded if they have been previously treated with anti-TNFα therapy (ENBREL, infliximab or adalimumab), IL-1ra, abatacept or B and T cell depleting therapies including rituximab or alemtuzumab. Subjects who have previously received other DMARD therapies including methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, gold, penicillamine, cyclosporine A, and cyclophosphamide must not have taken one of these medications within the past 30 days prior to instituting ENBREL.
- General: Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit. Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept.
- Prior or concurrent cyclophosphamide therapy. Concurrent sulfasalazine therapy. Known HIV-positive, mycobacterial disease, active severe infections, untreated Lyme disease, severe comorbidities, history of TB or TB exposure, chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy, history of recent alcohol or substance abuse (< 1 year), pregnant or lactating females and/or use of a live vaccine 90 days prior to, or during this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh - Oakland Falk Clinic
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Human TNFa-Induced Pre-B Cell Bone Marrow Emigrants
The purpose of the study is to determine the effects of TNF (tumor necrosis factor; a mediator of inflammation) on B cells in patients with rheumatoid arthritis. TNF and B cells are important in rheumatoid arthritis because they both appear to be involved in causing rheumatoid arthritis.
Read the detailed description
Primary Objective: The primary objective of the study is to identify early B cell bone marrow emigrants in the peripheral blood of adults with rheumatoid arthritis (RA) receiving etanercept.
Hypotheses: We believe that the peripheral blood of RA patients contain early B cell bone marrow emigrants. We believe that these early B cell bone marrow emigrants are induced by TNFα.
Primary Endpoint: The primary endpoint of the study is quantification of CD34+/CD19+ early B cell bone marrow emigrants in the peripheral blood of subjects.
Study Design: Open-label, One Arm, Phase IV study of 12 RA patients with active disease receiving etanercept.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etanercept
- Keywords
- rheumatoid arthritis, B lymphocytes
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called ENBREL
Etanercept 50 mg SQ qweek
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Not described Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to quantify early B cell bone marrow emigrants in the peripheral blood of adults with rheumatoid arthritis (RA) before and after etanercept therapy.
Measured: 12 weeks
Secondary outcomes (1)
Secondary objectives will include granulocyte numbers, serum cytokine (CRP, IL-1β and TNFα) levels, rheumatoid arthritis disease activity and changes in anti-CCP and RF levels before and after etanercept therapy.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: No subjects were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, MarcLevesque, University of Pittsburgh
- Investigators
- Marc C Levesque, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009879
- Sponsor's protocol ID
- AMGEN 2006_1112
- Status last verified
- Jun 2013
- First submitted
- 5 Nov 2009
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human TNFa-Induced Pre-B Cell Bone Marrow Emigrants
- ClinicalTrials.gov ID
- NCT01009879
- Acronym / sponsor ID
- AMGEN 2006_1112
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, B lymphocytes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Nov 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 9 Nov 2009 (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 the study is to determine the effects of TNF (tumor necrosis factor; a mediator of inflammation) on B cells in patients with rheumatoid arthritis. TNF and B cells are important in rheumatoid arthritis because they both appear to be involved in causing rheumatoid arthritis.
Detailed description
Primary Objective: The primary objective of the study is to identify early B cell bone marrow emigrants in the peripheral blood of adults with rheumatoid arthritis (RA) receiving etanercept.
Hypotheses: We believe that the peripheral blood of RA patients contain early B cell bone marrow emigrants. We believe that these early B cell bone marrow emigrants are induced by TNFα.
Primary Endpoint: The primary endpoint of the study is quantification of CD34+/CD19+ early B cell bone marrow emigrants in the peripheral blood of subjects.
Study Design: Open-label, One Arm, Phase IV study of 12 RA patients with active disease receiving etanercept.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: Etanercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Rheumatoid arthritis (RA) patients will be eligible for the study if they meet ACR criteria for a diagnosis of RA (Arnett et al. 1988. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis \& Rheumatism 31:315.) and have active disease (≥ 6 tender and/or swollen joints).
- Subjects must be ≥ 18 years of age.
- Subjects must be rheumatoid factor (RF) positive (any RF titer greater than the upper limits of normal) and/or anti-CCP antibody positive (any anti-CCP titer greater than the upper limits of normal). Subjects must have a negative TB skin test at entry into the study or a negative screening chest x-ray if the PPD test is inconclusive (borderline, reactive but non-diagnostic) or in prior BCG inoculated subjects. Female subjects of child bearing potential (excludes those that are surgically sterile or at least 5 years postmenopausal) must have a negative pregnancy test (serum β-HCG). Sexually active subjects of childbearing potential must agree to use medically acceptable forms of contraception during screening and throughout the study.
- Subjects or a designee must have the ability to self-inject ENBREL or a care-giver at home who can administer subcutaneous injections. Subjects must be willing to remain on ENBREL (50 mg SQ qweek) for at least 12 weeks and have not taken anti-rheumatic agents (DMARDS and/or corticosteroids) besides NSAIDs for the previous 4 weeks.
- The subject must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information. Before any study-specific procedure, the appropriate written informed consent must be obtained.
Key exclusion criteria (5 listed)
- RA patients will be excluded if they have a history of congestive heart failure, recurrent or active infection, a positive PPD, history of neurologic disease, Felty's syndrome, hematologic malignancy or liver disease.
- RA patients will be excluded if they have a WBC count < 4.0, Hct < 30 or liver profile abnormalities (> 2x normal values of AST, ALT, TBili and/or APhos).
- RA patients will be excluded if they have been previously treated with anti-TNFα therapy (ENBREL, infliximab or adalimumab), IL-1ra, abatacept or B and T cell depleting therapies including rituximab or alemtuzumab. Subjects who have previously received other DMARD therapies including methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, gold, penicillamine, cyclosporine A, and cyclophosphamide must not have taken one of these medications within the past 30 days prior to instituting ENBREL.
- General: Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit. Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept.
- Prior or concurrent cyclophosphamide therapy. Concurrent sulfasalazine therapy. Known HIV-positive, mycobacterial disease, active severe infections, untreated Lyme disease, severe comorbidities, history of TB or TB exposure, chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy, history of recent alcohol or substance abuse (< 1 year), pregnant or lactating females and/or use of a live vaccine 90 days prior to, or during this study.
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 |
|---|---|---|
| EtanerceptAlso: ENBRELEtanercept 50 mg SQ qweek | Drug | Etanercept |
Primary outcome
The primary objective of the study is to quantify early B cell bone marrow emigrants in the peripheral blood of adults with rheumatoid arthritis (RA) before and after etanercept therapy.
Time frame: 12 weeks
1 secondary outcome
Secondary objectives will include granulocyte numbers, serum cytokine (CRP, IL-1β and TNFα) levels, rheumatoid arthritis disease activity and changes in anti-CCP and RF levels before and after etanercept therapy.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
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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.
Marc C Levesque, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept in people with Rheumatoid Arthritis, run by University of Pittsburgh 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 2 Jul 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary objective of the study is to quantify early B cell bone marrow emigrants in the peripheral blood of adults with rheumatoid arthritis (RA) before and after etanercept therapy. (time frame: 12 weeks). 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 2 Jul 2013.