Rheumatoid ArthritisPhase 1NCT01011959
A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects
A Phase 1 study testing REGN88 in people with Rheumatoid Arthritis, run by Regeneron Pharmaceuticals at 24 sites in United States.
Trial summary
This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate. 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?
- REGN88
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 24 sitesUnited States
- Study dates
- Dec 2008to Aug 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an established diagnosis of Rheumatoid Arthritis
- Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks
Who cannot join
- Persistent chronic or current active infections
- Patients who have taken anakinra within 2 weeks
- Patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks
- Patients who have taken adalimumab within 6 weeks
- Patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks
- Patients who have taken leflunomide or rituximab within 6 months
Show all 9Show fewer
- Patients who have had prior treatment with tocilizumab or any other anti-IL-6 medication
- Significant arthritis or other medical condition that could interfere with study evaluations
- Participation in any clinical research study evaluating another investigational drug within 30 days
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Study site
Austin, Texas
Study site
Boca Raton, Florida
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Daytona Beach, Florida
Study site
Delray Beach, Florida
Study site
Duncansville, Pennsylvania
Study site
Flowood, Mississippi
Study site
Greenville, South Carolina
Study site
Hixson, Tennessee
Study site
Houston, Texas
Study site
Idaho Falls, Idaho
Study site
Kalamzaoo, Missouri
Study site
Lansing, Michigan
Study site
Oklahoma City, Oklahoma
Study site
Orangeburg, South Carolina
Study site
Palm Harbor, Florida
Study site
Reno, Nevada
Study site
San Antonio, Texas
Study site
Santa Maria, California
Study site
St Louis, Missouri
Study site
Toledo, Ohio
Study site
Worcester, Massachusetts
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate
This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.
Read the detailed description
This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate.
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will not begin until enrollment in Part B is complete.
- Conditions
- Rheumatoid Arthritis
- Being tested
- REGN88
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN88Biological
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | dose 1 vs. placebo Receives: Biological: REGN88 |
| 2 | Active comparator | dose 2 vs. placebo Receives: Biological: REGN88 |
| 3 | Active comparator | dose 3 vs. placebo Receives: Biological: REGN88 |
| 4 | Active comparator | dose 4 vs. placebo Receives: Biological: REGN88 |
| 5 | Active comparator | dose 5 vs. placebo Receives: Biological: REGN88 |
| 6 | Active comparator | dose 6 vs. placebo Receives: Biological: REGN88 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo
Measured: 10 weeks
Secondary outcomes (1)
To evaluate exploratory efficacy endpoints
Measured: over 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2009
- Study completionAug 2009
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 Regeneron PharmaceuticalsThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Allen Radin, MD, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011959
- Sponsor's protocol ID
- 6R88-RA-0802
- Status last verified
- Jun 2011
- First submitted
- 10 Nov 2009
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate
- ClinicalTrials.gov ID
- NCT01011959
- Acronym / sponsor ID
- 6R88-RA-0802
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Dec 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 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.
This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.
Detailed description
This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate.
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will not begin until enrollment in Part B is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: REGN88dose 1 vs. placebo |
| 2 | Active comparator | Biological: REGN88dose 2 vs. placebo |
| 3 | Active comparator | Biological: REGN88dose 3 vs. placebo |
| 4 | Active comparator | Biological: REGN88dose 4 vs. placebo |
| 5 | Active comparator | Biological: REGN88dose 5 vs. placebo |
| 6 | Active comparator | Biological: REGN88dose 6 vs. placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with an established diagnosis of Rheumatoid Arthritis
- Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks
Key exclusion criteria (9 listed)
- Persistent chronic or current active infections
- Patients who have taken anakinra within 2 weeks
- Patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks
- Patients who have taken adalimumab within 6 weeks
- Patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks
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 |
|---|---|---|
| REGN88This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete. | Biological | 1, 2, 3, 4, 5, 6 |
Primary outcome
Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo
Time frame: 10 weeks
1 secondary outcome
To evaluate exploratory efficacy endpoints
Time frame: over 10 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 30 Sep 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.
Allen Radin, MD study director
Regeneron Pharmaceuticals
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN88 in people with Rheumatoid Arthritis, run by Regeneron Pharmaceuticals at 24 sites 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 2 inclusion and 9 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 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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 treatment-emergent adverse events in patients treated with REGN88 and placebo (time frame: 10 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 30 Sep 2013.