Apoptotic DNA DamagePhase 4RANCT01717846
Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis
A Phase 4 study testing Group 1 or Orencia treated group and Group 2 (DMARDS treated group) in people with Apoptotic DNA Damage and Rheumatoid Arthritis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (RA) patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Apoptotic DNA Damage, Rheumatoid Arthritis, T-cell Lymphocytosis
- What is being tested?
- Group 1 or Orencia treated group and Group 2 (DMARDS treated group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Nov 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over age 18
- Meeting ACR Criteria 1987 for RA diagnosis
- Naïve to treatment with abatacept
- Must be able to understand information in the Informed Consent
Who cannot join
- Pregnancy or breast feeding
- Previous exposure to abatacept.
- History of a concomitant autoimmune disease (eg. SLE, PsA etc.)
- Patients with history of cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerity of California at Los Angeles
Los Angeles, California, 90095
About this study
Official title: In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis
This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.
Read the detailed description
Orencia may regulate apoptosis and apoptosis related genes in vivo in rheumatoid arthritis (RA) patient's cells. To date, no studies have been performed to evaluate the effect of Orencia on apoptosis in RA patients.
Primary: To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.
Secondary: To evaluate the association between the changes in apoptosis to changes in disease activity measures (DAS28/ESR) over 6 months of treatment with subcutaneous injection of abatacept.
- Being tested
- Group 1 or Orencia treated group, Group 2 (DMARDS treated group)
- Keywords
- Apoptosos, Rheumatoid Arthritis, T cells, B cells, DAS28, Clinical Disease activity Index, CDAI
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 or Orencia treated groupDrug
Also called Abatacept
Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.
Group 2 (DMARDS treated group)Other
Also called Arm 2 or group 2
Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Orencia Group is for RA patients who have not received any other biologic treatment, including abatacept previously, and whose doctor has determined that it is appropriate to treat their RA with Abatacept. If you are in Group 1, you will receive the study drug, Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form. Abatacept, given in an intravenous injection is approved by the FDA for the treatment of RA. Receives: Drug: Group 1 or Orencia treated group |
| Arm 2 or group 2 | Other | Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept. Receives: Other: Group 2 (DMARDS treated group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the change in apoptosis of T cells, B cells and antigen presenting (APC) cells in Rheumatoid Arthritis between the baseline, 3 months and at 6 months time points
To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.
Measured: Base line, 3 and 6 months
Secondary outcomes (1)
To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points
To measure the changes in disease activity score joint count (DAS28/ESR)
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2013 (estimated)
- Study completionNov 2014 (estimated)
Why it stopped: The PI has left UCLA and we do not plan to pursue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apoptotic DNA DamageStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Ram P Singh, MS, Ph.D., Principal investigator, University of California at Los Angeles, UCLAMihaela Taylor, MD, Study director, University of California at Los Angeles (UCLA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717846
- Sponsor's protocol ID
- IM101-356
- Other IDs
- IM101-356
- Acronym
- RA
- Status last verified
- May 2016
- First submitted
- 24 Oct 2012
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01717846
- Acronym / sponsor ID
- RA / IM101-356
- Keywords
- Apoptosos, Rheumatoid Arthritis, T cells, B cells, DAS28, Clinical Disease activity Index, CDAI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI has left UCLA and we do not plan to pursue this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 31 Oct 2012 (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.
This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.
Detailed description
Orencia may regulate apoptosis and apoptosis related genes in vivo in rheumatoid arthritis (RA) patient's cells. To date, no studies have been performed to evaluate the effect of Orencia on apoptosis in RA patients.
Primary: To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.
Secondary: To evaluate the association between the changes in apoptosis to changes in disease activity measures (DAS28/ESR) over 6 months of treatment with subcutaneous injection of abatacept.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Group 1 or Orencia treated groupOrencia Group is for RA patients who have not received any other biologic treatment, including abatacept previously, and whose doctor has determined that it is appropriate to treat their RA with Abatacept. If you are in Group 1, you will receive the study drug, Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form. Abatacept, given in an intravenous injection is approved by the FDA for the treatment of RA. |
| Arm 2 or group 2 | Other | Other: Group 2 (DMARDS treated group)Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over age 18
- Meeting ACR Criteria 1987 for RA diagnosis
- Naïve to treatment with abatacept
- Must be able to understand information in the Informed Consent
Key exclusion criteria (4 listed)
- Pregnancy or breast feeding
- Previous exposure to abatacept.
- History of a concomitant autoimmune disease (eg. SLE, PsA etc.)
- Patients with history of cancer
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 |
|---|---|---|
| Group 1 or Orencia treated groupAlso: AbataceptGroup 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months. | Drug | Arm 1 |
| Group 2 (DMARDS treated group)Also: Arm 2 or group 2Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept. | Other | Arm 2 or group 2 |
Primary outcome
To measure the change in apoptosis of T cells, B cells and antigen presenting (APC) cells in Rheumatoid Arthritis between the baseline, 3 months and at 6 months time points
Time frame: Base line, 3 and 6 months
To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.
1 secondary outcome
To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points
Time frame: Baseline, 3 and 6 months
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 11 May 2016.
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.
Ram P Singh, MS, Ph.D. principal investigator
University of California at Los Angeles, UCLA
Mihaela Taylor, MD study director
University of California at Los Angeles (UCLA)
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 Group 1 or Orencia treated group and Group 2 (DMARDS treated group) in people with Apoptotic DNA Damage and Rheumatoid Arthritis, run by University of California, Los Angeles 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 4 inclusion and 4 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 11 May 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 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?
To measure the change in apoptosis of T cells, B cells and antigen presenting (APC) cells in Rheumatoid Arthritis between the baseline, 3 months and at 6 months time points (time frame: Base line, 3 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 11 May 2016.