Rheumatoid ArthritisPhase 1NCT04704492
A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis
A Phase 1 study testing Biological: SM03 in people with Rheumatoid Arthritis, run by SinoMab BioScience Ltd at 1 site in China.
Trial summary
This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Biological: SM03
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2012to 16 Dec 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
- Moderate to severe active RA with swollen joint count (SJC) ≥ 6 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
- Receiving methotrexate (MTX) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks.
Who cannot join
- Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
- Rheumatic autoimmune disease other than RA.
- Use of any biological DMARDs for RA within past 6 months.
- Active infection, or history of serious or chronic infection.
- Any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease.
- Allergy or sensitivity to components of the drug vial or any of the materials used for infusion
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital
Beijing, 100032
About this study
Official title: An Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Preliminary Clinical Activity and Safety of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Patients With Rheumatoid Arthritis
This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.
Read the detailed description
This was an open phase I trial to evaluate the PK, PD, safety,tolerability, efficacy, and immunogenicity of SM03 in patients with RA. The total study duration was approximately 16 weeks for each participant, including a screening period of maximally 4 weeks, a multiple-dose period of 2 weeks (day 0 ~ day 14), and a post-treatment follow-up period of 10 weeks (day 15 ~ day 84).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Biological: SM03
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: SM03Drug
Also called SM03
Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2
| Study group | Role | What they receive |
|---|---|---|
| Biological: SM03 | Experimental | Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0 , 2. Receives: Drug: Biological: SM03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Time Cure(AUC0-t)
Pharmacokinetic endpoint: Area Under the Concentration Time Cure(AUC0-t)
Measured: Week 0 to 12
Time to Maximum Plasma Concentration (Tmax)
Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)
Measured: Week 0,2
Peak Plasma Concentration (Cmax)
Pharmacokinetic endpoint: Peak Plasma Concentration (Cmax)
Measured: Week 0, 2
Systemic Clearance (CL)
Pharmacokinetic endpoint: Systemic Clearance (CL)
Measured: Week 0 to 12
Terminal Half-life (T1/2)
Pharmacokinetic endpoint:Terminal Half-life (T1/2)
Measured: Week 0 to 12
Secondary outcomes (3)
Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Measured: Week 0 to 12
Number of ACR20, ACR50, and ACR70 Responders at Week 12
American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD \& IGAD
Measured: Week 2,4,8,12
Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The number of swollen and tender joints assessed using the 28-joint count; Erythrocyte sedimentation rate (ESR); Patient's global assessment of disease activity measured on a 10 cm visual analog scale.
The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
Measured: Week 0,2,4,8,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start14 Aug 2012
- Primary completion16 Dec 2013
- Study completion16 Dec 2013
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.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- SinoMab BioScience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pei Hu, PhD,MD, Principal investigator, Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704492
- Sponsor's protocol ID
- SM03-RA(I/II)-1.0
- Other IDs
- CTR20131127
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Preliminary Clinical Activity and Safety of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04704492
- Acronym / sponsor ID
- SM03-RA(I/II)-1.0
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- SinoMab BioScience LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2012 (actual)
- Primary completion
- 16 Dec 2013 (actual)
- Study completion
- 16 Dec 2013 (actual)
- First posted
- 11 Jan 2021 (actual)
- 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 was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.
Detailed description
This was an open phase I trial to evaluate the PK, PD, safety,tolerability, efficacy, and immunogenicity of SM03 in patients with RA. The total study duration was approximately 16 weeks for each participant, including a screening period of maximally 4 weeks, a multiple-dose period of 2 weeks (day 0 ~ day 14), and a post-treatment follow-up period of 10 weeks (day 15 ~ day 84).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological: SM03 | Experimental | Drug: Biological: SM03Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0 , 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
- Moderate to severe active RA with swollen joint count (SJC) ≥ 6 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
- Receiving methotrexate (MTX) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks.
Key exclusion criteria (6 listed)
- Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
- Rheumatic autoimmune disease other than RA.
- Use of any biological DMARDs for RA within past 6 months.
- Active infection, or history of serious or chronic infection.
- Any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease.
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 |
|---|---|---|
| Biological: SM03Also: SM03Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2 | Drug | Biological: SM03 |
Primary outcome
Area Under the Concentration Time Cure(AUC0-t)
Time frame: Week 0 to 12
Pharmacokinetic endpoint: Area Under the Concentration Time Cure(AUC0-t)
Time to Maximum Plasma Concentration (Tmax)
Time frame: Week 0,2
Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)
Peak Plasma Concentration (Cmax)
Time frame: Week 0, 2
Pharmacokinetic endpoint: Peak Plasma Concentration (Cmax)
Systemic Clearance (CL)
Time frame: Week 0 to 12
Pharmacokinetic endpoint: Systemic Clearance (CL)
Terminal Half-life (T1/2)
Time frame: Week 0 to 12
Pharmacokinetic endpoint:Terminal Half-life (T1/2)
3 secondary outcomes
Number of Participants Who Experienced at Least One Adverse Event
Time frame: Week 0 to 12
Number of ACR20, ACR50, and ACR70 Responders at Week 12
Time frame: Week 2,4,8,12
Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12
Time frame: Week 0,2,4,8,12
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 11 Jan 2021.
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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.
Pei Hu, PhD,MD principal investigator
Clinical Pharmacology Research Center & Translational Medicine Centre, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biological: SM03 in people with Rheumatoid Arthritis, run by SinoMab BioScience Ltd at 1 site in China.
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 6 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 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Area Under the Concentration Time Cure(AUC0-t) (time frame: Week 0 to 12). The study lists 5 primary outcomes in all. 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 11 Jan 2021.