Rheumatoid ArthritisPhase 2NCT02467504
Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis
A Phase 2 study testing hrIL-2 active, MTX and Folic Acid in people with Rheumatoid Arthritis, run by Peking University People's Hospital at 1 site in China.
Trial summary
Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by symmetric poly-arthritis usually involving the small joints of the hands and feet. In addition, various extra-joint manifestations may develop. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- hrIL-2 active, MTX and Folic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2015to 31 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 and ≤70 years of age at time of screening
- Diagnosed with rheumatoid arthritis
- Must have active disease with DMARDs (Disease Modifying Anti-Rheumatic Drugs) except MTX, the doses had been stable for at least 3 months before baseline
- Moderate or severe rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-ESR) > 3.2
- Have given written informed consent
Who cannot join
- Patient presenting or having a history of other inflammatory joint disease
- Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme
- Patient with significantly impaired bone marrow function or significant anaemia, leucopenia or thrombocytopenia due to causes or other than active rheumatoid arthritis
- Persistent infection or severe infection within 3 months before enrollment,
- Uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which, in the opinion of the investigator, would put the patient at risk to participate in the study,
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
Show all 22Show fewer
- Severe hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum albumin < 30 g/L
- Moderate or severe impairment of renal function, as known by serum creatinine > 133μmol/L (or 1.5 mg/dl)
- Patient with history of recent and clinically significant drug or alcohol abuse
- Impairment of liver function or persisting ALT (SGPT) elevations of more than 2-fold the upper limit of normal
- Known HIV positive status
- Known positive serology for hepatitis B or C
- Patient with hypersensitivity to any of the excipients in the tablets of methotrexate
- Pregnancy
- Breastfeeding
- Women of childbearing potential, except if they fulfill specific conditions,
- Men wishing to father children during the course of the study or within the 24 months thereafter (or 3 month with the washout procedure)
- Patient with a congenital or acquired severe immuno-deficiency, a history of cancer or lymphoproliferative disease, or any patient who has received total lymphoid irradiation.
- Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research
- Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose
- BMI(body mass index) under 18.5 kg/m2 or more than 30 kg/m2
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis
Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by symmetric poly-arthritis usually involving the small joints of the hands and feet. In addition, various extra-joint manifestations may develop. Several immunomodulating agents have been attempted in the treatment of RA without achieving satisfactory results. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active RA patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2 (N = 23) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 24)).
Read the detailed description
Each RA patients (n=47) with DAS>3.2 received low-dose IL-2+MTX+ Loxoprofen or placebo+MTX + Loxoprofen (active group: placebo group =1:1, 1 million units every other day subcutaneously (hrIL-2 1×106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.
- Conditions
- Rheumatoid Arthritis
- Being tested
- hrIL-2 active, hrIL-2 placebo, MTX, Folic Acid, Loxoprofen
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hrIL-2 activeDrug
Also called Human recombinant IL-2
hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
hrIL-2 placeboDrug
Also called placebo
hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTXDrug
Methotrexate (oral administration)
Folic AcidDrug
Folic Acid (oral administration)
LoxoprofenDrug
Loxoprofen (oral administration)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen Receives: Drug: hrIL-2 active; Drug: MTX; Drug: Folic Acid; Drug: Loxoprofen |
| Placebo Comparator | Placebo comparator | hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen Receives: Drug: hrIL-2 placebo; Drug: MTX; Drug: Folic Acid; Drug: Loxoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving DAS28 Remission.
DAS 28 remission is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 2.6
Measured: week 24
Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria
The assessments are based on a 20% or greater improvement from Baseline in the number of tender joints, a 20%, or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Measured: week 12, week 24
The Change From Baseline of Clinical Disease Activity Index (CDAI)
Clinical Disease Activity Index(CDAI), the minimum is 0, the maximum is 76. higher scores mean a worse outcome.
The change of from baseline of CDAI, the minimum is -76, the maximum is 76. higher scores mean a worse outcome.
Measured: week 12, week 24
The Change From Baseline of Simplified Disease Activity Index (SDAI)
Simplified Disease Activity Index(SDAI). the minimum is 0, the maximum is 96. higher scores mean worse outcome.
The change from baseline of SDAI. the minimum is -96, the maximum is 96. higher scores mean worse outcome.
Measured: week 12, week 24
Secondary outcomes (16)
Number of Participants With Adverse Events
adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event, drug-induced liver and kidney damage.
Measured: Up to week 24
Percentage of CD4+ Treg Cells
analysis regulatory CD4+ T(Treg) cells before and during IL-2 treatment. P values<0.05 are considered statistically significant.
Measured: week 12, week 24
Percentage of Participants Achieving DAS28 Low Disease Activity.
Low disease activity is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 3.2
Measured: week 12, week 24
Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response
Good response is defined as: DAS28-ESR ≤ 3.2 and decrease from Baseline by > 1.2.
moderate response is defined as achievement of one of the following: DAS28-ESR ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2 DAS28-ESR > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6 DAS28-ESR > 5.1 and decrease from Baseline >1.2.
Measured: week 12, week 24
Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria
The assessments are based on a 50% or greater improvement from Baseline in the number of tender joints, a 50%, or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Measured: week 12, week 24
Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria
The assessments are based on a 70% or greater improvement from Baseline in the number of tender joints, a 70%, or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Measured: week 12, week 24
Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice
The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.
Measured: week 12, week 24
The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI)
The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The total score ranges from 0 to 3 with lower scores meaning lower disability.
The change from baseline of HAQ-DI, minimum is -3, the maximum is 3. higher scores mean a worse outcome.
Measured: week 12, week 24
The Scores of SF-36 Quetionnaire
Score ranging from 0 to 100 with higher scores a better outcome.
Measured: week 12, week 24
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]
The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).higher scores mean a worse outcome.
Measured: week 24
Erythrocyte Sedimentation Rate (ESR)
Measured: week 12, week 24
C Reactive Protein (CRP)
Measured: week 12, week 24
The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA)
VAS score from 0 to 100 for Patient's Global Assessment of Disease Activity Higher scores mean a worse outcome. The change from baseline of PtGADA, the minimum is -100, the maximum is 100. Higher scores mean a worse outcome.
Measured: week 12, week 24
The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA)
VAS score from 0 to 100 for Physician's Global Assessment of Disease Activity higher scores mean a worse outcome. The change from baseline, the minimum is -100, the maximum is 100.
Measured: week 12, week 24
The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP)
VAS score from 0 to 100 for Patient's Assessment of Arthritis Pain higher scores mean a worse outcome. The change from baseline of PtAAP, the minimum is -100, the maximum is 100.
Measured: week 12, week 24
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2
In the last month, number of work days missed, number of work days with reduced productivity. In the last month, number of days with no household work, number of days with reduced household work productivity, number of days with hired outside help, number of days missed of family/social/leisure activities in the last month.higher scores mean a worse outcome.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start1 Jul 2015
- Primary completion15 Jan 2017
- Study completion31 Aug 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, Beijing ShuangLu Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Zhanguo Li, Peking University People's Hospital
- Investigators
- Zhanguo Li, MD PhD, Principal investigator, Peking University Institute of Rheuamotology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467504
- Sponsor's protocol ID
- hrIL-2 RA
- Status last verified
- May 2019
- First submitted
- 4 Jun 2015
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zhang X, Miao M, Zhang R, Liu X, Zhao X, Shao M, Liu T, Jin Y, Chen J, Liu H, Zhang X, Li Y, Zhou Y, Yang Y, Li R, Yao H, Liu Y, Li C, Li Y, Ren L, Su Y, Sun X, He J, Li Z. Efficacy and safety of low-dose interleukin-2 in combination with methotrexate in patients with active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2022 Mar 7;7(1):67. doi: 10.1038/s41392-022-00887-2.
PubMed 35250032
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02467504
- Acronym / sponsor ID
- hrIL-2 RA
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Monash University, Beijing ShuangLu Pharmaceutical Co., Ltd.
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by symmetric poly-arthritis usually involving the small joints of the hands and feet. In addition, various extra-joint manifestations may develop. Several immunomodulating agents have been attempted in the treatment of RA without achieving satisfactory results. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active RA patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2 (N = 23) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 24)).
Detailed description
Each RA patients (n=47) with DAS>3.2 received low-dose IL-2+MTX+ Loxoprofen or placebo+MTX + Loxoprofen (active group: placebo group =1:1, 1 million units every other day subcutaneously (hrIL-2 1×106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Drug: hrIL-2 active, Drug: MTX, Drug: Folic Acid, Drug: LoxoprofenhrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen |
| Placebo Comparator | Placebo comparator | Drug: hrIL-2 placebo, Drug: MTX, Drug: Folic Acid, Drug: LoxoprofenhrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 and ≤70 years of age at time of screening
- Diagnosed with rheumatoid arthritis
- Must have active disease with DMARDs (Disease Modifying Anti-Rheumatic Drugs) except MTX, the doses had been stable for at least 3 months before baseline
- Moderate or severe rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-ESR) > 3.2
- Have given written informed consent
Key exclusion criteria (22 listed)
- Patient presenting or having a history of other inflammatory joint disease
- Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme
- Patient with significantly impaired bone marrow function or significant anaemia, leucopenia or thrombocytopenia due to causes or other than active rheumatoid arthritis
- Persistent infection or severe infection within 3 months before enrollment,
- Uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which, in the opinion of the investigator, would put the patient at risk to participate in the study,
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 |
|---|---|---|
| hrIL-2 activeAlso: Human recombinant IL-2hrIL-2 active (1 million U doses of hrIL-2s.c.injection) | Drug | Experimental |
| hrIL-2 placeboAlso: placebohrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection) | Drug | Placebo Comparator |
| MTXMethotrexate (oral administration) | Drug | Experimental, Placebo Comparator |
| Folic AcidFolic Acid (oral administration) | Drug | Experimental, Placebo Comparator |
| LoxoprofenLoxoprofen (oral administration) | Drug | Experimental, Placebo Comparator |
Primary outcome
Percentage of Participants Achieving DAS28 Remission.
Time frame: week 24
DAS 28 remission is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 2.6
Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria
Time frame: week 12, week 24
The assessments are based on a 20% or greater improvement from Baseline in the number of tender joints, a 20%, or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
The Change From Baseline of Clinical Disease Activity Index (CDAI)
Time frame: week 12, week 24
Clinical Disease Activity Index(CDAI), the minimum is 0, the maximum is 76. higher scores mean a worse outcome. The change of from baseline of CDAI, the minimum is -76, the maximum is 76. higher scores mean a worse outcome.
The Change From Baseline of Simplified Disease Activity Index (SDAI)
Time frame: week 12, week 24
Simplified Disease Activity Index(SDAI). the minimum is 0, the maximum is 96. higher scores mean worse outcome. The change from baseline of SDAI. the minimum is -96, the maximum is 96. higher scores mean worse outcome.
16 secondary outcomes
Number of Participants With Adverse Events
Time frame: Up to week 24
Percentage of CD4+ Treg Cells
Time frame: week 12, week 24
Percentage of Participants Achieving DAS28 Low Disease Activity.
Time frame: week 12, week 24
Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response
Time frame: week 12, week 24
Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria
Time frame: week 12, week 24
Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria
Time frame: week 12, week 24
Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice
Time frame: week 12, week 24
The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI)
Time frame: week 12, week 24
The Scores of SF-36 Quetionnaire
Time frame: week 12, week 24
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]
Time frame: week 24
Erythrocyte Sedimentation Rate (ESR)
Time frame: week 12, week 24
C Reactive Protein (CRP)
Time frame: week 12, week 24
The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA)
Time frame: week 12, week 24
The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA)
Time frame: week 12, week 24
The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP)
Time frame: week 12, week 24
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2
Time frame: week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35250032Zhang X, Miao M, Zhang R, Liu X, Zhao X, Shao M, Liu T, Jin Y, Chen J, Liu H, Zhang X, Li Y, Zhou Y, Yang Y, Li R, Yao H, Liu Y, Li C, Li Y, Ren L, Su Y, Sun X, He J, Li Z. Efficacy and safety of low-dose interleukin-2 in combination with methotrexate in patients with active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2022 Mar 7;7(1):67. doi: 10.1038/s41392-022-00887-2.
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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.
Zhanguo Li, MD PhD principal investigator
Peking University Institute of Rheuamotology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hrIL-2 active, MTX and Folic Acid in people with Rheumatoid Arthritis, run by Peking University People's Hospital 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 5 inclusion and 22 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 9 Sep 2019. 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. 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 9 Sep 2019). 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?
Percentage of Participants Achieving DAS28 Remission. (time frame: week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467504, which also lists 1 linked publication.
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 9 Sep 2019.