Arthritis, RheumatoidPhase 1NCT00815906
Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
A Phase 1 study testing SBI-087 in people with Arthritis, Rheumatoid, run by Pfizer at 7 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- SBI-087
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesJapan
- Study dates
- Dec 2008to May 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must meet American College of Rheumatology criteria for rheumatoid arthritis with functional class I to III.
- Rheumatoid arthritis disease onset at >16 years of age and duration of disease at least 6 months.
- Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at the screening visit.
Who cannot join
- Any significant health problems other than rheumatoid arthritis.
- Treatment of greater than 10 mg of prednisone per day.
- Therapy with immunosuppressants within 6 months before study day 1
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Pfizer Investigational Site
Ehime
Pfizer Investigational Site
Fukui
Pfizer Investigational Site
Kanagawa
Pfizer Investigational Site
Miyagi
Pfizer Investigational Site
Ōita
Pfizer Investigational Site
Shizuoka
Pfizer Investigational Site
Tokyo
About this study
Official title: An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis
The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- SBI-087
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBI-087Drug
IV, Single dose
SBI-087Drug
IV, Single dose
SBI-087Drug
SC, Single dose
SBI-087Drug
SC, Single dose
| Study group | Role | What they receive |
|---|---|---|
| SBI-087 0.15 mg IV | Experimental | Not described Receives: Drug: SBI-087 |
| SBI-087 0.5 mg IV | Experimental | Not described Receives: Drug: SBI-087 |
| SBI-087 100 mg SC | Experimental | Not described Receives: Drug: SBI-087 |
| SBI-087 200 mg SC | Experimental | Not described Receives: Drug: SBI-087 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
Measured: 12 months
Secondary outcomes (3)
To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA
Measured: 12 months
To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087
Measured: 12 month
To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emergent Product Development Seattle LLC
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815906
- Sponsor's protocol ID
- 3227K1-1001
- Other IDs
- B2261002
- Status last verified
- Aug 2024
- First submitted
- 18 Dec 2008
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00815906
- Acronym / sponsor ID
- 3227K1-1001
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Emergent Product Development Seattle LLC
- Study start
- Dec 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Dec 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 evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SBI-087 0.15 mg IV | Experimental | Drug: SBI-087 |
| SBI-087 0.5 mg IV | Experimental | Drug: SBI-087 |
| SBI-087 100 mg SC | Experimental | Drug: SBI-087 |
| SBI-087 200 mg SC | Experimental | Drug: SBI-087 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must meet American College of Rheumatology criteria for rheumatoid arthritis with functional class I to III.
- Rheumatoid arthritis disease onset at >16 years of age and duration of disease at least 6 months.
- Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at the screening visit.
Key exclusion criteria (3 listed)
- Any significant health problems other than rheumatoid arthritis.
- Treatment of greater than 10 mg of prednisone per day.
- Therapy with immunosuppressants within 6 months before study day 1
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 |
|---|---|---|
| SBI-087IV, Single dose | Drug | SBI-087 0.15 mg IV |
| SBI-087IV, Single dose | Drug | SBI-087 0.5 mg IV |
| SBI-087SC, Single dose | Drug | SBI-087 100 mg SC |
| SBI-087SC, Single dose | Drug | SBI-087 200 mg SC |
Primary outcome
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
Time frame: 12 months
3 secondary outcomes
To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA
Time frame: 12 months
To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087
Time frame: 12 month
To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087
Time frame: 12 month
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 14 Aug 2024.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
7 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 SBI-087 in people with Arthritis, Rheumatoid, run by Pfizer at 7 sites in Japan.
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 3 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: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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?
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels (time frame: 12 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 14 Aug 2024.