Rheumatoid ArthritisPhase 1NCT00718588
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis
A Phase 1 study testing MTRX1011A in people with Rheumatoid Arthritis, run by Genentech, Inc..
Trial summary
This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- MTRX1011A
- Type of treatment
- Injection or infusion
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SAD Stage
- RA diagnosed according to the ACR
- For patients taking anti-rheumatic therapies, receipt of a stable regimen prior to randomization
- Previous treatment with biologic agents, including anti-TNF agents, permitted but discontinued for an appropriate washout period
- MAD Stage (same as above with the addition of the following)
- Failure of at least one biologic agent, defined as lack of or loss of response or intolerance
- Active disease defined by swollen and tender count
Who cannot join
- Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty's syndrome
- Malignancy, or prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ that has been resected
- History of treatment with any T cell-directed therapy
About this study
Official title: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis
This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA.
- Conditions
- Rheumatoid Arthritis
- Being tested
- MTRX1011A
- Keywords
- RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTRX1011ADrug
Subcutaneous and intravenous single and repeating dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of MTRX1011A in both the SAD and MAD stages
Measured: Length of study
Secondary outcomes (2)
Characterize the pharmacokinetic response of MTRX1011A
Measured: Length of study
Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
Why it stopped: Study had completed enrollment but drug injection was halted due to an unacceptable incidence of rash.
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 Genentech, Inc.The 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Davis, M.D., M.P.H., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718588
- Sponsor's protocol ID
- CDT4478g
- Status last verified
- Mar 2012
- First submitted
- 16 Jul 2008
- Last updated
- 7 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00718588
- Acronym / sponsor ID
- CDT4478g
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study had completed enrollment but drug injection was halted due to an unacceptable incidence of rash.
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 18 Jul 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.
This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- SAD Stage
- MAD Stage (same as above with the addition of the following)
Key exclusion criteria (3 listed)
- Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty's syndrome
- Malignancy, or prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ that has been resected
- History of treatment with any T cell-directed therapy
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 |
|---|---|---|
| MTRX1011ASubcutaneous and intravenous single and repeating dose | Drug | – |
Primary outcome
Safety and tolerability of MTRX1011A in both the SAD and MAD stages
Time frame: Length of study
2 secondary outcomes
Characterize the pharmacokinetic response of MTRX1011A
Time frame: Length of study
Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A
Time frame: Length of study
Results and safety
The study was stopped early (reason given: Study had completed enrollment but drug injection was halted due to an unacceptable incidence of rash.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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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.
John Davis, M.D., M.P.H. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTRX1011A in people with Rheumatoid Arthritis, run by Genentech, Inc..
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Study had completed enrollment but drug injection was halted due to an unacceptable incidence of rash.). Results are not available in the source record.
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?
Safety and tolerability of MTRX1011A in both the SAD and MAD stages (time frame: Length of study). 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 7 Mar 2012.