Active Rheumatoid ArthritisPhase 2NCT01008852
Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis
A Phase 2 study testing SBI-087 in people with Active Rheumatoid Arthritis, run by Pfizer at 55 sites in 10 countries.
Trial summary
This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Rheumatoid Arthritis
- What is being tested?
- SBI-087
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 55 sitesin 10 countries
- Study dates
- Dec 2009to Jul 2013
- Phase
- Phase 2
- 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
- Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
- Active RA as defined by >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
- Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
- Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)
Who cannot join
- Any significant health problem other than rheumatoid arthritis
- Any clinically significant laboratory abnormalities
- Any prior use of B cell-depleting therapy
Trial locations and contacts
55 sites in 10 countries.
55 sites in 10 countries
United States20 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Charleston, South Carolina, 29406
Pfizer Investigational Site
Clarksburg, West Virginia, 26301
Pfizer Investigational Site
Dayton, Ohio, 45408
Pfizer Investigational Site
Grand Rapids, Michigan, 49546
Pfizer Investigational Site
Jackson, Tennessee, 38305
Pfizer Investigational Site
Miami, Florida, 33169
Pfizer Investigational Site
Minot, North Dakota, 58701
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Palm Desert, California, 92260
Pfizer Investigational Site
Palm Harbor, Florida, 34684
Pfizer Investigational Site
Paradise Valley, Arizona, 85253
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
Springfield, Illinois, 62704
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Toledo, Ohio, 43606
Pfizer Investigational Site
Tulsa, Oklahoma, 74135
Pfizer Investigational Site
Westlake Village, California, 91361
Pfizer Investigational Site
Worcester, Massachusetts, 01610
Japan10 sites
Pfizer Investigational Site
Aichi
Pfizer Investigational Site
Fukui
Pfizer Investigational Site
Fukuoka
Pfizer Investigational Site
Hokkaido
Pfizer Investigational Site
Hyōgo
Pfizer Investigational Site
Kanagawa
Pfizer Investigational Site
Miyagi
Pfizer Investigational Site
Saitama
Pfizer Investigational Site
Shizuoka
Pfizer Investigational Site
Tokyo
Poland5 sites
Pfizer Investigational Site
Działdowo, 13-200
Pfizer Investigational Site
Elblag, 82-300
Pfizer Investigational Site
Sopot, 81-759
Pfizer Investigational Site
Warsaw, Poland, 04-141
Pfizer Investigational Site
Warsaw, 02-637
Canada4 sites
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 3J1
Pfizer Investigational Site
Toronto, Ontario, M5T 2S8
Pfizer Investigational Site
Toronto, Ontario, M9L 3A2
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1M3
Hungary4 sites
Pfizer Investigational Site
Budapest, 1023
Pfizer Investigational Site
Gyula, 5701
Pfizer Investigational Site
Miskolc, 3529
Pfizer Investigational Site
Szolnok, 5000
Spain4 sites
Pfizer Investigational Site
A Coruña, A Coruña, 15006
Pfizer Investigational Site
Madrid, Madrid, 28007
Pfizer Investigational Site
Madrid, Madrid, 28046
Pfizer Investigational Site
Seville, Sevilla, 41009
Argentina3 sites
Pfizer Investigational Site
Buenos Aires, C.a.b.a., C1015ABO
Pfizer Investigational Site
C.a.b.a, C1055AAF
Pfizer Investigational Site
C.a.b.a, C1425EKG
Serbia3 sites
Pfizer Investigational Site
Belgrade, 11000
Pfizer Investigational Site
Niška Banja, 18205
Pfizer Investigational Site
Novi Sad, 21000
Chile1 site
Pfizer Investigational Site
Providencia, Santiago Metropolitan, 7601126
About this study
Official title: Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate
This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.
- Conditions
- Active Rheumatoid Arthritis
- Being tested
- SBI-087, Placebo
- Keywords
- rheumatoid arthritis, seropositive, methotrexate
- 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
200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
SBI-087Drug
200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
SBI-087Drug
200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
SBI-087Drug
200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
PlaceboDrug
Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Not described Receives: Drug: SBI-087 |
| Treatment Group 2 | Experimental | Not described Receives: Drug: SBI-087 |
| Treatment Group 3 | Experimental | Not described Receives: Drug: SBI-087 |
| Treatment Group 4 | Experimental | Not described Receives: Drug: SBI-087 |
| Treatment Group 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response as measured by American College of Rheumatology criteria (ACR 20 response)
Measured: 16 weeks
Secondary outcomes (1)
ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Rheumatoid ArthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 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
- NCT01008852
- Sponsor's protocol ID
- 3227K1-2000
- Other IDs
- B2261003
- Status last verified
- Nov 2013
- First submitted
- 5 Nov 2009
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate
- ClinicalTrials.gov ID
- NCT01008852
- Acronym / sponsor ID
- 3227K1-2000
- Conditions
- Active Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, seropositive, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Emergent Product Development Seattle LLC
- Study start
- Dec 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 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 study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: SBI-087 |
| Treatment Group 2 | Experimental | Drug: SBI-087 |
| Treatment Group 3 | Experimental | Drug: SBI-087 |
| Treatment Group 4 | Experimental | Drug: SBI-087 |
| Treatment Group 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
- Active RA as defined by >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
- Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
- Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)
Key exclusion criteria (3 listed)
- Any significant health problem other than rheumatoid arthritis
- Any clinically significant laboratory abnormalities
- Any prior use of B cell-depleting 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 |
|---|---|---|
| SBI-087200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate | Drug | Treatment Group 1 |
| SBI-087200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate | Drug | Treatment Group 2 |
| SBI-087200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate | Drug | Treatment Group 3 |
| SBI-087200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate | Drug | Treatment Group 4 |
| PlaceboPlacebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate | Drug | Treatment Group 5 |
Primary outcome
Response as measured by American College of Rheumatology criteria (ACR 20 response)
Time frame: 16 weeks
1 secondary outcome
ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response
Time frame: up to 24 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 3 Dec 2013.
- 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
55 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBI-087 in people with Active Rheumatoid Arthritis, run by Pfizer at 55 sites in 10 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 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 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Japan, Poland, Canada, Hungary and 5 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response as measured by American College of Rheumatology criteria (ACR 20 response) (time frame: 16 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 3 Dec 2013.