Rheumatoid ArthritisPhase 2NCT02047604
(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
A Phase 2 study testing SAN-300 0.5 mg/kg QW, SAN-300 1.0 mg/kg QW and SAN-300 2.0 mg/kg QOW in people with Rheumatoid Arthritis, run by Bausch Health Americas, Inc. at 12 sites in United States.
Trial summary
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SAN-300 0.5 mg/kg QW, SAN-300 1.0 mg/kg QW and SAN-300 2.0 mg/kg QOW
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2013to 23 Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010
- 18 to 75 years of age, inclusive, at the time of informed consent
- Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
- Inadequate response to therapy or discontinuation of therapy because of unacceptable toxicity from at least one prior traditional or biologic disease-modifying anti-rheumatic drug (DMARD)
- Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization
Who cannot join
- Functional Class IV as defined by ACR classification of functional status in RA
- History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
- History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible
- Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases
- History of recurrent clinically significant infections
- Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
Show all 18Show fewer
- History of severe allergic or anaphylactic reactions to other biologic agents
- History of allergies to murine protein
- Surgery within 3 months before randomization (other than minor cosmetic surgery or minor dental procedures) or plans for a surgical procedure during the Treatment Period or Follow-up Period
- History of tuberculosis or latent infection currently undergoing treatment
- History of malaria
- Treatment regimen with prednisone that is either over 10 mg/day (or equivalent dose of another corticosteroid) or is not taken at a stable dose of ≤ 10 mg/day for at least 4 weeks before randomization
- Intra-articular corticosteroid injection(s) within 4 weeks before randomization
- Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
- Abnormal laboratory value at Screening or Day -1 considered clinically significant
- Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
- Positive for human immunodeficiency virus (HIV) antibody
- History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Santarus Clinical Investigational Site 1013
Brandon, Florida, 33511
Santarus Clinical Investigational Site 1009
Brooklyn, New York, 11201
Santarus Clinical Investigational Site 1019
Chapel Hill, North Carolina, 27599
Santarus Clinical Investigational Site 1014
Charlotte, North Carolina, 28210
Santarus Clinical Investigational Site 1004
El Cajon, California, 92020
Santarus Clinical Investigational Site 1017
Florissant, Missouri, 63031
Santarus Clinical Investigational Site 1008
Los Angeles, California, 90048
Santarus Clinical Investigational Site 1001
Middleburg Heights, Ohio, 44130
Santarus Clinical Investigational Site 1003
Palm Harbor, Florida, 34684
Santarus Clinical Investigational Site 1012
Phoenix, Arizona, 85023
Santarus Clinical Investigational Site 1006
Salisbury, North Carolina, 28144
Santarus Clinical Investigational Site 1011
San Leandro, California, 94578
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
- Conditions
- Rheumatoid Arthritis
- Being tested
- SAN-300 0.5 mg/kg QW, SAN-300 1.0 mg/kg QW, SAN-300 2.0 mg/kg QOW, SAN-300 4.0 mg/kg QOW, SAN-300 4.0 mg/kg QW
- Keywords
- Phase 2a multiple ascending dose, Anti-Very Late Antigen-1
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAN-300 0.5 mg/kg QWDrug
SAN-300 1.0 mg/kg QWDrug
SAN-300 2.0 mg/kg QOWDrug
SAN-300 4.0 mg/kg QOWDrug
SAN-300 4.0 mg/kg QWDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - SAN-300 0.5 mg/kg QW | Experimental | SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks Receives: Drug: SAN-300 0.5 mg/kg QW |
| Cohort B - SAN-300 1.0 mg/kg QW | Experimental | SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks Receives: Drug: SAN-300 1.0 mg/kg QW |
| Cohort C - SAN-300 2.0 mg/kg QOW | Experimental | SAN-300 2.0 mg/kg subcutaneous every other week for six weeks Receives: Drug: SAN-300 2.0 mg/kg QOW |
| Cohort D - SAN-300 4.0 mg/kg QOW | Experimental | SAN-300 4.0 mg/kg subcutaneous every other week for six weeks Receives: Drug: SAN-300 4.0 mg/kg QOW |
| Cohort E - SAN-300 4.0 mg/kg QW | Experimental | SAN-300 4.0 mg/kg subcutaneous every other week for six weeks Receives: Drug: SAN-300 4.0 mg/kg QW |
| Placebo | Placebo comparator | Placebo dosing Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.
Measured: 10 weeks
Secondary outcomes (2)
Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)
DAS28-CRP= 0.56 x sqrt(TJC28) x sqrt(SJC28) + 0.36 x ln(CRP+1) +0.014 x VAS +0.96 Where TJC28: The number of tender joints (0-28). SJC28: The number of swollen joints (0-28). CRP: The C-Reactive Protein level (in mg/l). VAS General Health Assessment (from 0=best to 100=worst). ln=natural log. sqrt = square root. Higher scores indicate worse outcome.
Measured: Baseline, End of Treatment Visit (Week 7)
Number of Participants With American College of Rheumatology 20 (ACR20) Response.
A participant is considered to have an ACR20 response if there is an improvement of 20% in all of the following:
- Swollen joint count (66 joints)
- Tender joint count (68 joints) and
- At least three of the following five assessments:
- Patient's assessment of pain
- Patient's global assessment of disease activity
- Physician's global assessment of disease activity
- Patient's assessment of physical function, as measured by the HAQ-DI
- CRP
Measured: End of Treatment Visit (Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startDec 2013
- Primary completion23 Feb 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047604
- Sponsor's protocol ID
- C2013-0302
- Other IDs
- 2013-003719-23
- Status last verified
- Jun 2021
- First submitted
- 22 Jan 2014
- Last updated
- 21 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
- ClinicalTrials.gov ID
- NCT02047604
- Acronym / sponsor ID
- C2013-0302
- Conditions
- Rheumatoid Arthritis
- Keywords
- Phase 2a multiple ascending dose, Anti-Very Late Antigen-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 21 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A - SAN-300 0.5 mg/kg QW | Experimental | Drug: SAN-300 0.5 mg/kg QWSAN-300 0.5 mg/kg subcutaneous once weekly for six weeks |
| Cohort B - SAN-300 1.0 mg/kg QW | Experimental | Drug: SAN-300 1.0 mg/kg QWSAN-300 1.0 mg/kg subcutaneous once weekly for six weeks |
| Cohort C - SAN-300 2.0 mg/kg QOW | Experimental | Drug: SAN-300 2.0 mg/kg QOWSAN-300 2.0 mg/kg subcutaneous every other week for six weeks |
| Cohort D - SAN-300 4.0 mg/kg QOW | Experimental | Drug: SAN-300 4.0 mg/kg QOWSAN-300 4.0 mg/kg subcutaneous every other week for six weeks |
| Cohort E - SAN-300 4.0 mg/kg QW | Experimental | Drug: SAN-300 4.0 mg/kg QWSAN-300 4.0 mg/kg subcutaneous every other week for six weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo dosing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010
- 18 to 75 years of age, inclusive, at the time of informed consent
- Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
- Inadequate response to therapy or discontinuation of therapy because of unacceptable toxicity from at least one prior traditional or biologic disease-modifying anti-rheumatic drug (DMARD)
- Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization
Key exclusion criteria (18 listed)
- Functional Class IV as defined by ACR classification of functional status in RA
- History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
- History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible
- Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases
- History of recurrent clinically significant infections
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 |
|---|---|---|
| SAN-300 0.5 mg/kg QW | Drug | Cohort A - SAN-300 0.5 mg/kg QW |
| SAN-300 1.0 mg/kg QW | Drug | Cohort B - SAN-300 1.0 mg/kg QW |
| SAN-300 2.0 mg/kg QOW | Drug | Cohort C - SAN-300 2.0 mg/kg QOW |
| SAN-300 4.0 mg/kg QOW | Drug | Cohort D - SAN-300 4.0 mg/kg QOW |
| SAN-300 4.0 mg/kg QW | Drug | Cohort E - SAN-300 4.0 mg/kg QW |
| Placebo | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: 10 weeks
Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.
2 secondary outcomes
Change From Baseline in Disease Activity Score With 28-joint Count Using C-reactive Protein (DAS28-CRP)
Time frame: Baseline, End of Treatment Visit (Week 7)
Number of Participants With American College of Rheumatology 20 (ACR20) Response.
Time frame: End of Treatment Visit (Week 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAN-300 0.5 mg/kg QW, SAN-300 1.0 mg/kg QW and SAN-300 2.0 mg/kg QOW in people with Rheumatoid Arthritis, run by Bausch Health Americas, Inc. at 12 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 5 inclusion and 18 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 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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. 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?
Yes. Results are posted in the registry (first posted 21 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (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 21 Jun 2021.