Rheumatoid ArthritisPhase 1MDX1342-01NCT00639834
Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
A Phase 1 study testing MDX-1342 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 24 sites in 5 countries.
Trial summary
The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed. 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?
- MDX-1342
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Feb 2008to Jun 2010
- 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
- Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA)
- Must have active RA
- Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
- All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration
Who cannot join
- Both Rheumatoid factor and anti-CCP negative
- Prior treatment with any B-cell depleting therapy
- Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit
- History of or current inflammatory joint disease other than RA
- Neuropathies or neurovasculopathies that might interfere with pain evaluation
- Complications of RA or other disease
Show all 9Show fewer
- Any other autoimmune disease other than RA
- Acute or chronic infection
- Clinically significant disease requiring
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States11 sites
Good Samaritan Hospital and Johns Hopkins Hospital
Baltimore, Maryland, 21239
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Centre for Rheumatology, Immunology and Arthritis (CRIA)
Fort Lauderdale, Florida, 33334
Justus Fiechtner
Lansing, Michigan, 48910
Impact Clinical Trials
Los Angeles, California, 90036
Columbia University Medical Center
New York, New York, 10032
Sun Valley Arthritis Center LTD.
Peoria, Arizona, 85381
Coastal Medical Research, Inc
Port Orange, Florida, 32127
Arthritis Northwest Rheumatology, PLLC
Spokane, Washington, 99204
George Krick, MD
Tacoma, Washington, 98405
Lovelace Scientific Resources
Venice, Florida, 34233
Hungary4 sites
DRC Gyógyszervizsgáló Központ Kft
Balatonfüred, H-8230
Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz
Budapest, H-1083
DEOEC Kinikai Farmakologiai Tanszek
Debrecen, H-4012
First Department of Medicine
Szeged
Ukraine4 sites
V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic
Donetsk, 83045
Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25
Kharkiv, 61115
Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department
Zaporizhya, 69035
Zaporizhzhya Regional Clinical Hospital, Rheumatology Department
Zaporizhzhya, 69600
Germany3 sites
klinikum der Universitat zu Koln
Cologne, 50924
Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden
Dresden, 01307
Klinikum rechts der Isar der TU Munchen
Munich, 81675
United Kingdom2 sites
The Kellgren Centre for Rheumatology
Manchester
Welcome Trust Clinical Research Facility, Southampton General Hospital
Southampton, SO16 6YD
About this study
Official title: A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis
The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed.
- Conditions
- Rheumatoid Arthritis
- Being tested
- MDX-1342
- Keywords
- rheumatoid, arthritis, RA, joint inflammation, autoimmune, Medarex, Rheumatology
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX-1342Biological
One dose of active MDX-1342 (anti-CD19 fully human monoclonal antibody) will be administered to patients as an i.v. infusion. Patients will receive one dose of MDX-1342 given in combination with Methotrexate treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active MDX-1342 given in combination with Methotrexate Receives: Biological: MDX-1342 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of treatment-emergent adverse events
Measured: all adverse events will be followed to resolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2010
- Study completionJun 2010
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 Bristol-Myers SquibbThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639834
- Sponsor's protocol ID
- MDX1342-01
- Other IDs
- IM130-001
- Acronym
- MDX1342-01
- Status last verified
- May 2013
- First submitted
- 10 Jan 2008
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00639834
- Acronym / sponsor ID
- MDX1342-01 / MDX1342-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid, arthritis, RA, joint inflammation, autoimmune, Medarex, Rheumatology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Mar 2008 (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 determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MDX-1342Active MDX-1342 given in combination with Methotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA)
- Must have active RA
- Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
- All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration
Key exclusion criteria (9 listed)
- Both Rheumatoid factor and anti-CCP negative
- Prior treatment with any B-cell depleting therapy
- Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit
- History of or current inflammatory joint disease other than RA
- Neuropathies or neurovasculopathies that might interfere with pain evaluation
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 |
|---|---|---|
| MDX-1342One dose of active MDX-1342 (anti-CD19 fully human monoclonal antibody) will be administered to patients as an i.v. infusion. Patients will receive one dose of MDX-1342 given in combination with Methotrexate treatment. | Biological | 1 |
Primary outcome
incidence and severity of treatment-emergent adverse events
Time frame: all adverse events will be followed to resolution
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 22 May 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MDX-1342 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 24 sites in 5 countries.
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 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 22 May 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, Hungary, Ukraine, Germany, United Kingdom. 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 and severity of treatment-emergent adverse events (time frame: all adverse events will be followed to resolution). 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 22 May 2013.