Trial Outcomes & Findings for Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis (NCT NCT02467504)
NCT ID: NCT02467504
Last Updated: 2019-09-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
week 24
Results posted on
2019-09-09
Participant Flow
Participant milestones
| Measure |
Experimental
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
17
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental
n=23 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=24 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 10.9 • n=23 Participants
|
56.4 years
STANDARD_DEVIATION 9.9 • n=24 Participants
|
54.5 years
STANDARD_DEVIATION 10.5 • n=47 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
20 Participants
n=23 Participants
|
20 Participants
n=24 Participants
|
40 Participants
n=47 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
3 Participants
n=23 Participants
|
4 Participants
n=24 Participants
|
7 Participants
n=47 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: week 24DAS 28 remission is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 2.6
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Percentage of Participants Achieving DAS28 Remission.
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: week 12, week 24The 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).
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria
week 24
|
13 Participants
|
13 Participants
|
|
Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria
week 12
|
12 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: week 12, week 24Clinical 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.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
The Change From Baseline of Clinical Disease Activity Index (CDAI)
week 24
|
-17.5 score on a scale
Interval -22.0 to -11.0
|
-11 score on a scale
Interval -17.5 to -7.0
|
|
The Change From Baseline of Clinical Disease Activity Index (CDAI)
week 12
|
-15.0 score on a scale
Interval -19.0 to -9.7
|
-8.0 score on a scale
Interval -16.9 to -3.5
|
PRIMARY outcome
Timeframe: week 12, week 24Simplified 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.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
The Change From Baseline of Simplified Disease Activity Index (SDAI)
week 24
|
-19.0 score on a scale
Interval -23.1 to -12.2
|
-12.1 score on a scale
Interval -19.3 to -6.3
|
|
The Change From Baseline of Simplified Disease Activity Index (SDAI)
week 12
|
-16.9 score on a scale
Interval -19.1 to -9.8
|
-9.2 score on a scale
Interval -17.2 to -3.9
|
SECONDARY outcome
Timeframe: Up to week 24adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event, drug-induced liver and kidney damage.
Outcome measures
| Measure |
Experimental
n=23 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=24 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Number of Participants With Adverse Events
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: week 12, week 24analysis regulatory CD4+ T(Treg) cells before and during IL-2 treatment. P values\<0.05 are considered statistically significant.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Percentage of CD4+ Treg Cells
Week 24
|
6.94 percentage of CD4+ T cells
Interval 2.18 to 13.77
|
6.46 percentage of CD4+ T cells
Interval 3.71 to 12.3
|
|
Percentage of CD4+ Treg Cells
Week 12
|
6.84 percentage of CD4+ T cells
Interval 3.7 to 10.61
|
5.37 percentage of CD4+ T cells
Interval 3.2 to 7.86
|
SECONDARY outcome
Timeframe: week 12, week 24Low disease activity is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 3.2
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Percentage of Participants Achieving DAS28 Low Disease Activity.
week 24
|
8 Participants
|
9 Participants
|
|
Percentage of Participants Achieving DAS28 Low Disease Activity.
week 12
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: week 12, week 24Good 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.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response
week 24
|
17 Participants
|
20 Participants
|
|
Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response
week 12
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: week 12, week 24The 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).
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria
week 24
|
10 Participants
|
8 Participants
|
|
Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria
weed 12
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: week 12, week 24The 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).
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria
week 24
|
4 Participants
|
2 Participants
|
|
Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria
week 12
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 12, week 24The 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.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice
week 24
|
2 Participants
|
1 Participants
|
|
Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice
week 12
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 12, week 24The 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.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI)
week 24
|
-0.63 score on a scale
Interval -0.88 to -0.13
|
-0.38 score on a scale
Interval -0.75 to 0.0
|
|
The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI)
week 12
|
-0.50 score on a scale
Interval -0.88 to -0.19
|
-0.25 score on a scale
Interval -0.63 to 0.0
|
SECONDARY outcome
Timeframe: week 12, week 24Score ranging from 0 to 100 with higher scores a better outcome.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
The Scores of SF-36 Quetionnaire
week 12
|
24.32 score on a scale
Interval 11.89 to 40.85
|
27.25 score on a scale
Interval 16.58 to 41.47
|
|
The Scores of SF-36 Quetionnaire
week 24
|
15.29 score on a scale
Interval 8.73 to 29.65
|
6.90 score on a scale
Interval 1.39 to 16.61
|
SECONDARY outcome
Timeframe: week 24The 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.
Outcome measures
| Measure |
Experimental
n=23 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=24 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]
rate of Arthritis interference
|
3 units on a scale
Interval 0.0 to 6.75
|
2 units on a scale
Interval 0.0 to 6.5
|
|
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]
Rate of arthritis interference with household work
|
5 units on a scale
Interval 3.0 to 10.0
|
5 units on a scale
Interval 2.25 to 6.0
|
SECONDARY outcome
Timeframe: week 12, week 24Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR)
Week 24
|
43.3 millimeter/hour
Standard Deviation 25.9
|
36.8 millimeter/hour
Standard Deviation 24.9
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 12
|
29.6 millimeter/hour
Standard Deviation 25.6
|
28.3 millimeter/hour
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: week 12, week 24Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
C Reactive Protein (CRP)
week 12
|
9.5 mg/L
Standard Deviation 9.0
|
7.8 mg/L
Standard Deviation 7.2
|
|
C Reactive Protein (CRP)
week 24
|
21.6 mg/L
Standard Deviation 20.83
|
15.32 mg/L
Standard Deviation 14.74
|
SECONDARY outcome
Timeframe: week 12, week 24VAS 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.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA)
week 24
|
-57.5 score on a scale
Interval -76.4 to -29.5
|
-33.3 score on a scale
Interval -66.7 to 0.0
|
|
The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA)
week 12
|
-57.1 score on a scale
Interval -75.0 to -35.4
|
-33.3 score on a scale
Interval -62.5 to 0.0
|
SECONDARY outcome
Timeframe: week 12, week 24VAS 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.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA)
week 24
|
-58.3 score on a scale
Interval -76.4 to -47.2
|
-44.4 score on a scale
Interval -57.1 to 0.0
|
|
The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA)
week 12
|
-57.1 score on a scale
Interval -66.7 to -33.3
|
-25.0 score on a scale
Interval -44.4 to 0.0
|
SECONDARY outcome
Timeframe: week 12, week 24VAS 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.
Outcome measures
| Measure |
Experimental
n=17 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=23 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP)
week 24
|
-57.5 score on a scale
Interval -76.4 to -29.5
|
-33.3 score on a scale
Interval -66.7 to 0.0
|
|
The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP)
week 12
|
-57.1 score on a scale
Interval -69.6 to -41.5
|
-27.3 score on a scale
Interval -42.7 to 0.0
|
SECONDARY outcome
Timeframe: week 24In 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.
Outcome measures
| Measure |
Experimental
n=23 Participants
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=24 Participants
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2
Days with outside help hired due to arthritis
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
|
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2
number of work days with reduced productivity
|
3.5 days
Interval 0.0 to 20.0
|
0 days
Interval 0.0 to 18.0
|
|
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2
number of work days missed
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
|
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2
Household work days missed due to arthritis
|
0 days
Interval 0.0 to 10.0
|
0 days
Interval 0.0 to 6.5
|
|
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2
Days with household work productivity reduced
|
15 days
Interval 3.0 to 30.0
|
12 days
Interval 5.0 to 30.0
|
|
Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2
Days with activities missed due to arthritis
|
5 days
Interval 0.0 to 7.0
|
0 days
Interval 0.0 to 7.0
|
Adverse Events
Experimental
Serious events: 2 serious events
Other events: 9 other events
Deaths: 11 deaths
Placebo Comparator
Serious events: 1 serious events
Other events: 8 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Experimental
n=23 participants at risk
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=24 participants at risk
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Surgical and medical procedures
Hospitalized not related to RA
|
8.7%
2/23 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Experimental
n=23 participants at risk
hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
Placebo Comparator
n=24 participants at risk
hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
hrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
MTX: Methotrexate (oral administration)
Folic Acid: Folic Acid (oral administration)
Loxoprofen: Loxoprofen (oral administration)
|
|---|---|---|
|
Gastrointestinal disorders
gastrointestinal disorders
|
8.7%
2/23 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic enzyme increased
|
4.3%
1/23 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Injection site reactions
|
13.0%
3/23 • Number of events 3
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
1/23 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fever after injection
|
8.7%
2/23 • Number of events 2
|
0.00%
0/24
|
|
Immune system disorders
Worsening of RA
|
4.3%
1/23 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
Additional Information
Prof. Zhanguo Li
Peking university People's Hospital
Phone: +86-13810001444
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place