Trial Outcomes & Findings for An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients. (NCT NCT02590562)
NCT ID: NCT02590562
Last Updated: 2017-08-02
Results Overview
Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. Biological agent monotherapy included biological agent only, biological agent + glucocorticoid, biological agent + non-steroidal anti-inflammatory drugs \[NSAIDs\], and biological agent + glucocorticoid + NSAIDs.
Recruitment status
COMPLETED
Target enrollment
808 participants
Primary outcome timeframe
Day 1 (enrollment visit)
Results posted on
2017-08-02
Participant Flow
Participant milestones
| Measure |
Overall Population
Participants diagnosed with rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) 1987 criteria who were using biological disease-modifying anti-rheumatic drugs (DMARDs) approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
|---|---|
|
Overall Study
STARTED
|
808
|
|
Overall Study
COMPLETED
|
802
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Overall Population
Participants diagnosed with rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) 1987 criteria who were using biological disease-modifying anti-rheumatic drugs (DMARDs) approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
|---|---|
|
Overall Study
Did Not Meet the Inclusion Criteria
|
6
|
Baseline Characteristics
An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.
Baseline characteristics by cohort
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 13.89 • n=5 Participants
|
|
Age, Customized
less than or equal to (<=) 20 years
|
12 participants
n=5 Participants
|
|
Age, Customized
greater than (>) 20 to <=40 years
|
201 participants
n=5 Participants
|
|
Age, Customized
>40 to <=60 years
|
402 participants
n=5 Participants
|
|
Age, Customized
>60 years
|
185 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
652 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population
Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. Biological agent monotherapy included biological agent only, biological agent + glucocorticoid, biological agent + non-steroidal anti-inflammatory drugs \[NSAIDs\], and biological agent + glucocorticoid + NSAIDs.
Outcome measures
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy
Biological agent only
|
44 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy
Biological agent+ glucocorticoid
|
9 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy
Biological agent + NSAIDs
|
26 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy
Biological agent + glucocorticoid + NSAIDs
|
5 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy
Biological agent concomitant with csDMARDs
|
718 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population
Number of participants receiving treatment of a biological agent concomitant with the following drugs: glucocorticoid, NSAIDs, other external medicine, or concomitant glucocorticoid and concomitant NSAIDs. The same participant could use 2 or 3 of concomitant glucocorticoid, NSAIDs and other external medicine.
Outcome measures
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants Receiving a Biological Agent Concomitant With Other Drugs
Concomitant with glucocorticoid
|
238 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving a Biological Agent Concomitant With Other Drugs
Concomitant with NSAIDs
|
450 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving a Biological Agent Concomitant With Other Drugs
Concomitant with glucocorticoid and NSAIDs
|
137 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving a Biological Agent Concomitant With Other Drugs
Concomitant other external medicine
|
153 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Number of participants who received a biological agent as monotherapy is presented by biological agent (adalimumab, tocilizumab, etanercept, and infliximab).
Outcome measures
| Measure |
Overall Population
n=84 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents
Adalimumab
|
4 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents
Tocilizumab
|
8 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents
Infliximab
|
9 participants
|
—
|
—
|
—
|
|
Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents
Etanercept
|
63 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified treatment of biological agent.
Average weekly dose of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.
Outcome measures
| Measure |
Overall Population
n=783 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Average Weekly Dose of Treatment for Each Biological Agent
Adalimumab (n=60)
|
20.1 milligrams (mg) per week
Standard Deviation 6.41
|
—
|
—
|
—
|
|
Average Weekly Dose of Treatment for Each Biological Agent
Tocilizumab (n=136)
|
94.5 milligrams (mg) per week
Standard Deviation 21.90
|
—
|
—
|
—
|
|
Average Weekly Dose of Treatment for Each Biological Agent
Etanercept (n=534)
|
38.2 milligrams (mg) per week
Standard Deviation 15.64
|
—
|
—
|
—
|
|
Average Weekly Dose of Treatment for Each Biological Agent
Infliximab (n=53)
|
33.1 milligrams (mg) per week
Standard Deviation 23.55
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. n = participants with specified treatment of biological agent.
Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.
Outcome measures
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Average Duration of Treatment for Each Biological Agent
Infliximab (n=69)
|
34.5 weeks
Standard Deviation 39.07
|
—
|
—
|
—
|
|
Average Duration of Treatment for Each Biological Agent
Adalimumab (n=60)
|
12.7 weeks
Standard Deviation 19.39
|
—
|
—
|
—
|
|
Average Duration of Treatment for Each Biological Agent
Tocilizumab (n=138)
|
4.7 weeks
Standard Deviation 7.48
|
—
|
—
|
—
|
|
Average Duration of Treatment for Each Biological Agent
Etanercept (n=535)
|
25.5 weeks
Standard Deviation 47.02
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population
Participants who used the same biological agent in the past and were using that same biological agent at the time of study enrollment.
Outcome measures
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Previous Use of the Same Biological Agent
|
58 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Participants who used a different biological agent in the past and switched are shown by reason for switching. One participant could have switched types of biological agent due to multiple reasons.
Outcome measures
| Measure |
Overall Population
n=93 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past
Adverse reaction
|
13 participants
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past
Economic reasons
|
10 participants
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past
Unsatisfactory efficacy
|
54 participants
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past
Improvement of the disease
|
10 participants
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past
Inconvenient administration
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past
Voluntarily discontinuation
|
7 participants
|
—
|
—
|
—
|
|
Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past
Other reasons
|
6 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified concomitant glucocorticoid treatment.
Average weekly dose of each concomitant glucocorticoid (prednisone acetate, oral; betamethasone \[BMZ\] dipropionate and betamethasone sodium phosphate, intra-articular (IA) injection; and methylprednisolone, intravenous drip infusion, oral) is presented.
Outcome measures
| Measure |
Overall Population
n=235 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Average Weekly Dose of Each Concomitant Glucocorticoid
Prednisone acetate, oral (n=174)
|
57.8 mg/week
Standard Deviation 31.93
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant Glucocorticoid
BMZ dipropionate and BMZ sodium phosphate, IA(n=2)
|
3.8 mg/week
Standard Deviation 4.54
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant Glucocorticoid
Methylprednisolone, intravenous drip infusion(n=4)
|
638.8 mg/week
Standard Deviation 368.61
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant Glucocorticoid
Methylprednisolone, oral (n=55)
|
59.7 mg/week
Standard Deviation 151.60
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
Outcome measures
| Measure |
Overall Population
n=153 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Average Duration of Treatment With Each Concomitant External Medicine
Dogskin paste (n=2)
|
5.5 weeks
Standard Deviation 4.95
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Tianhe ostealgia plaster (n=1)
|
4.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Ketoprofen (n=46)
|
2.0 weeks
Standard Deviation 4.06
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Xiaotong plaster (n=5)
|
83.2 weeks
Standard Deviation 45.62
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Anti-inflammatory analgesic ointment (n=1)
|
1.1 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Missing (n=1)
|
1.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Baiyi anti-inflammatory analgesic plaster (n=1)
|
1.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Tibetan medicine (n=1)
|
24.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Flurbiprofen (n=2)
|
4.5 weeks
Standard Deviation 4.95
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Compound Nanxing analgesic plaster (n=1)
|
1.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Indirect moxibustion (n=1)
|
1.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Dogskin plaster (n=1)
|
10.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Analgesic plaster for arthritis (n=4)
|
90.5 weeks
Standard Deviation 83.35
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Hantongle plaster (n=1)
|
1.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Safflower oil (n=1)
|
1.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Wong To Yick Winter Green Oil (n=1)
|
40.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Activating collaterals Liniment (n=1)
|
4.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Flavored Shuangbai Powder (n=16)
|
16.9 weeks
Standard Deviation 27.99
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Capsaicin (n=13)
|
5.1 weeks
Standard Deviation 7.13
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Kilo-Mile Medicine Oil (n=1)
|
4.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Qingpeng ointment (n=5)
|
40.8 weeks
Standard Deviation 39.76
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Shuangbai powder (n=5)
|
3.0 weeks
Standard Deviation 4.47
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Diclofenac (n=32)
|
7.8 weeks
Standard Deviation 26.39
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Antiphlogistic analgesic ointment (n=1)
|
5.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Yunnan Baiyao plaster (n=3)
|
59.0 weeks
Standard Deviation 84.54
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Chinese patent medicine (n=2)
|
2.0 weeks
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Indometacin (n=1)
|
4.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Musk tiger bone plaster (n=1)
|
10.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Musk analgesic spray (n=1)
|
1.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant External Medicine
Shexiang Zhuanggu plaster (n=1)
|
3.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Number of participants using one concomitant csDMARD, two concomitant csDMARDs (methotrexate + hydroxychloroquine \[HCQ\], methotrexate + salazosulfapyridine \[SASP\], methotrexate+ leflunomide, SASP + HCQ, and other combinations), or three (or more) concomitant csDMARDs (methotrexate + SASP + HCQ, and other combinations) are presented.
Outcome measures
| Measure |
Overall Population
n=718 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
Two csDMARDs: Methotrexate + SASP
|
7 participants
|
—
|
—
|
—
|
|
Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
Two csDMARDs: Methotrexate+ leflunomide
|
83 participants
|
—
|
—
|
—
|
|
Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
One csDMARDs
|
354 participants
|
—
|
—
|
—
|
|
Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
Two csDMARDs: Methotrexate + HCQ
|
129 participants
|
—
|
—
|
—
|
|
Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
Two csDMARDs: SASP + HCQ
|
9 participants
|
—
|
—
|
—
|
|
Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
Two csDMARDs: Other combinations
|
68 participants
|
—
|
—
|
—
|
|
Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
Three(or more) csDMARDs: Methotrexate + SASP + HCQ
|
10 participants
|
—
|
—
|
—
|
|
Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs
Three (or more) csDMARDs: Other combinations
|
58 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
One participant could have received multiple concomitant csDMARDs treatment.
Outcome measures
| Measure |
Overall Population
n=718 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Average Weekly Dose of Each Concomitant csDMARD
Iguratimod (n=8)
|
46.9 mg/week
Standard Deviation 8.84
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Cyclophosphamide (n=7)
|
26.9 mg/week
Standard Deviation 18.68
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Ciclosporin (n=2)
|
75.0 mg/week
Standard Deviation 35.36
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Methotrexate (n=473)
|
1.4 mg/week
Standard Deviation 0.35
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Leflunomide (n=298)
|
15.4 mg/week
Standard Deviation 5.22
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Chloroquine phosphate (n=1)
|
250.0 mg/week
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Azathioprine (n=1)
|
50.0 mg/week
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Sulfasalazine (n=45)
|
1753.3 mg/week
Standard Deviation 693.26
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Mycophenolate mofetil (n=2)
|
625.0 mg/week
Standard Deviation 530.33
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Minocycline (n=1)
|
100.0 mg/week
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Penicillamine (n=8)
|
343.8 mg/week
Standard Deviation 57.86
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Thalidomide (n=4)
|
75.0 mg/week
Standard Deviation 28.87
|
—
|
—
|
—
|
|
Average Weekly Dose of Each Concomitant csDMARD
Hydroxychloroquine (n=300)
|
340.3 mg/week
Standard Deviation 96.25
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
One participant could have received multiple concomitant csDMARDs treatment.
Outcome measures
| Measure |
Overall Population
n=718 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Average Duration of Treatment With Each Concomitant csDMARD
Leflunomide (n=296)
|
413.4 weeks
Standard Deviation 578.53
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Iguratimod (n=6)
|
260.8 weeks
Standard Deviation 121.84
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Cyclophosphamide (n=7)
|
251.1 weeks
Standard Deviation 230.78
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Ciclosporin (n=2)
|
448.0 weeks
Standard Deviation 554.37
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Methotrexate (n=468)
|
443.7 weeks
Standard Deviation 845.76
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Chloroquine phosphate (n=1)
|
95.2 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Azathioprine (n=1)
|
0.7 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Sulfasalazine (n=45)
|
429.1 weeks
Standard Deviation 1039.86
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Mycophenolate mofetil (n=2)
|
10.2 weeks
Standard Deviation 4.45
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Minocycline (n=1)
|
210.0 weeks
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Penicillamine (n=8)
|
768.8 weeks
Standard Deviation 1012.51
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Thalidomide (n=4)
|
234.5 weeks
Standard Deviation 208.79
|
—
|
—
|
—
|
|
Average Duration of Treatment With Each Concomitant csDMARD
Hydroxychloroquine (n=298)
|
261.3 weeks
Standard Deviation 409.44
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
One participant could have received multiple concomitant NSAIDs treatment.
Outcome measures
| Measure |
Overall Population
n=450 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Nimesulide (n=18)
|
186.1 mg/day
Standard Deviation 41.32
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Celecoxib (n=194)
|
306.2 mg/day
Standard Deviation 100.07
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Diclofenac (n=31)
|
130.6 mg/day
Standard Deviation 166.55
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Imrecoxib (n=20)
|
200.0 mg/day
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Ibuprofen (n=12)
|
550.0 mg/day
Standard Deviation 173.21
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Aceclofenac (n=7)
|
157.1 mg/day
Standard Deviation 53.45
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Lornoxicam (n=6)
|
16.0 mg/day
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Loxoprofen sodium (n=54)
|
143.9 mg/day
Standard Deviation 45.28
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Meloxicam (n=91)
|
12.8 mg/day
Standard Deviation 3.45
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Etoricoxib (n=26)
|
86.5 mg/day
Standard Deviation 32.12
|
—
|
—
|
—
|
|
Average Daily Dose of Each Currently Concomitant NSAIDs
Indometacin (n=1)
|
75.0 mg/day
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.
One participant could have received multiple concomitant NSAIDs treatment.
Outcome measures
| Measure |
Overall Population
n=98 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Average Daily Dose of Each Previously Concomitant NSAIDs
Ibuprofen (n=8)
|
525.0 mg/day
Standard Deviation 148.80
|
—
|
—
|
—
|
|
Average Daily Dose of Each Previously Concomitant NSAIDs
Aceclofenac (n=2)
|
150.0 mg/day
Standard Deviation 70.71
|
—
|
—
|
—
|
|
Average Daily Dose of Each Previously Concomitant NSAIDs
Loxoprofen sodium (n=16)
|
135.0 mg/day
Standard Deviation 46.48
|
—
|
—
|
—
|
|
Average Daily Dose of Each Previously Concomitant NSAIDs
Meloxicam (n=18)
|
13.1 mg/day
Standard Deviation 3.69
|
—
|
—
|
—
|
|
Average Daily Dose of Each Previously Concomitant NSAIDs
Nimesulide (n=1)
|
200.0 mg/day
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
|
Average Daily Dose of Each Previously Concomitant NSAIDs
Celecoxib (n=39)
|
266.7 mg/day
Standard Deviation 95.51
|
—
|
—
|
—
|
|
Average Daily Dose of Each Previously Concomitant NSAIDs
Diclofenac (n=12)
|
83.3 mg/day
Standard Deviation 40.36
|
—
|
—
|
—
|
|
Average Daily Dose of Each Previously Concomitant NSAIDs
Etoricoxib (n=3)
|
60.0 mg/day
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Average Daily Dose of Each Previously Concomitant NSAIDs
Indometacin (n=1)
|
75.0 mg/day
Standard Deviation NA
Standard deviation was not available as there was only 1 participant analyzed for this category.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population
Outcome measures
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage
Concurrent chronic disease
|
275 participants
|
—
|
—
|
—
|
|
Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage
Tuberculosis history
|
2 participants
|
—
|
—
|
—
|
|
Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage
Hepatitis history
|
8 participants
|
—
|
—
|
—
|
|
Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage
Imaging of joint damage
|
279 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Overall Population
n=799 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Weight
|
58.9 kilograms
Standard Deviation 10.55
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Overall Population
n=797 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Height
|
161.6 centimeters (cm)
Standard Deviation 6.56
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
RA related operations also included prosthesis.
Outcome measures
| Measure |
Overall Population
n=801 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of RA Related Operations
|
0.1 RA related operations
Standard Deviation 0.34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25
Outcome measures
| Measure |
Overall Population
n=357 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
RA Duration Since Diagnosis
|
3.2 years
Standard Deviation 5.80
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Number of participants with RA duration of \<= 6 months, \>6 months and \<= 3 years, \>3 years and \<= 10 years, and 10 years.
Outcome measures
| Measure |
Overall Population
n=357 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With RA Duration
<=6 months
|
176 participants
|
—
|
—
|
—
|
|
Number of Participants With RA Duration
>6 months and <=3 years
|
80 participants
|
—
|
—
|
—
|
|
Number of Participants With RA Duration
>3 years and <=10 years
|
59 participants
|
—
|
—
|
—
|
|
Number of Participants With RA Duration
10 years
|
42 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Number of participants with concurrent RA extra-articular symptoms including RA subcutaneous nodule, RA vasculitis, interstitial pneumonia, Felty's syndrome, and other symptoms were presented. One participant could have more than one concurrent RA extra-articular symptoms.
Outcome measures
| Measure |
Overall Population
n=41 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Concurrent RA Extra-articular Symptoms
RA nodule
|
18 participants
|
—
|
—
|
—
|
|
Number of Participants With Concurrent RA Extra-articular Symptoms
Vasculitis
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Concurrent RA Extra-articular Symptoms
Interstitial pneumonia
|
22 participants
|
—
|
—
|
—
|
|
Number of Participants With Concurrent RA Extra-articular Symptoms
Felty's syndrome
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Concurrent RA Extra-articular Symptoms
Other symptoms
|
2 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Overall Population
n=22 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate
|
5 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
Overall Population
n=344 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
C-Reactive Protein (CRP) Values
|
27.7 mg/L
Standard Deviation 33.91
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Central lab was not used in this study; the definitions of abnormal CRP followed participating hospitals' standardized criteria. Case report form (CRF) collected data as directly "normal" or "abnormal".
Outcome measures
| Measure |
Overall Population
n=344 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal CRP Values
|
209 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.
Outcome measures
| Measure |
Overall Population
n=394 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR) Values
|
42.4 mm/hr
Standard Deviation 31.10
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. Central lab was not used in this study; the definitions of abnormal ESR followed participating hospitals' standardized criteria. CRF collected data as directly "normal" or "abnormal".
Outcome measures
| Measure |
Overall Population
n=394 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal ESR Values
|
276 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Hemoglobin levels were measured in gram per liter (g/L). Anemia was defined as an adult male with hemoglobin value \<120 g/L or an adult female with hemoglobin value \<110 g/L.
Outcome measures
| Measure |
Overall Population
n=411 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Hemoglobin Values
|
117.1 g/L
Standard Deviation 18.78
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Anemia was defined as an adult male with hemoglobin value \<120 g/L or an adult female with hemoglobin value \<110 g/L.
Outcome measures
| Measure |
Overall Population
n=411 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Anemia
|
147 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
ACCP antibodies are important markers of bone erosion in RA. Central lab was not used in this study; the definitions of positive ACCP followed participating hospitals' standardized criteria. CRF collected data as "positive" or "negative" directly.
Outcome measures
| Measure |
Overall Population
n=173 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody
|
144 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. Central lab was not used in this study; the definitions of positive RF followed participating hospitals' standardized criteria. CRF collected data as "positive" or "negative" directly.
Outcome measures
| Measure |
Overall Population
n=237 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Positive Rheumatoid Factor (RF)
|
184 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Normal range for triglyceride is \<1.7 millimoles per liter (mmol/L).
Outcome measures
| Measure |
Overall Population
n=226 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Triglyceride Values
|
1.3 mmol/L
Standard Deviation 0.71
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Normal range for triglyceride is \<1.7 mmol/L.
Outcome measures
| Measure |
Overall Population
n=226 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Triglyceride Values
|
47 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Normal range for total cholesterol is \<5.2 mmol/L.
Outcome measures
| Measure |
Overall Population
n=233 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Total Cholesterol Values
|
4.3 mmol/L
Standard Deviation 1.23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Normal range for total cholesterol is \<5.2 mmol/L.
Outcome measures
| Measure |
Overall Population
n=233 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Total Cholesterol Values
|
35 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population
Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28.
Outcome measures
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Swollen Joint Count (SJC)
|
4.8 swollen joint count
Standard Deviation 6.06
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.
Outcome measures
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Tender Joint Count (TJC)
|
6.7 tender joint count
Standard Deviation 7.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and Patient's Global Assessment (PtGA) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale \[VAS\] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*PtGA of disease activity; DAS28-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(10\*CRP+1) + 0.014\*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.
Outcome measures
| Measure |
Overall Population
n=412 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
|
4.4 units on a scale
Standard Deviation 1.52
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*PtGA of disease activity; DAS28-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(10\*CRP+1) + 0.014\*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.
Outcome measures
| Measure |
Overall Population
n=412 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28
High disease activity
|
135 participants
|
—
|
—
|
—
|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28
Moderate disease activity
|
174 participants
|
—
|
—
|
—
|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28
Low disease activity
|
51 participants
|
—
|
—
|
—
|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28
Remission
|
52 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician's Global Assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity.
Outcome measures
| Measure |
Overall Population
n=801 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Clinical Disease Activity Index (CDAI) Scores
|
20.2 units on a scale
Standard Deviation 15.25
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity.
Outcome measures
| Measure |
Overall Population
n=801 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI
High disease activity
|
278 participants
|
—
|
—
|
—
|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI
Moderate disease activity
|
273 participants
|
—
|
—
|
—
|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI
Low disease activity
|
207 participants
|
—
|
—
|
—
|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI
Remission
|
43 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \<=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity.
Outcome measures
| Measure |
Overall Population
n=343 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Simplified Disease Activity Index (SDAI)
|
27.2 units on a scale
Standard Deviation 18.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \<=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity.
Outcome measures
| Measure |
Overall Population
n=343 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI
High disease activity
|
158 participants
|
—
|
—
|
—
|
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Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI
Moderate disease activity
|
117 participants
|
—
|
—
|
—
|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI
Low disease activity
|
56 participants
|
—
|
—
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—
|
|
Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI
Remission
|
12 participants
|
—
|
—
|
—
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SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population
Number of participants with duration of treatment of biological agent \<3 months, \>= 3 to \<6 months, \>= 6 to \<12 months, and \>= 12 months.
Outcome measures
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
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Number of Participants With Duration of Treatment of Biological Agent
<3 months
|
503 participants
|
—
|
—
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—
|
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Number of Participants With Duration of Treatment of Biological Agent
>=3 to <6 months
|
86 participants
|
—
|
—
|
—
|
|
Number of Participants With Duration of Treatment of Biological Agent
>=6 to <12 months
|
96 participants
|
—
|
—
|
—
|
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Number of Participants With Duration of Treatment of Biological Agent
>=12 months
|
117 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure in respective arms.
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*PtGA of disease activity; DAS28-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(10\*CRP+1) + 0.014\*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.
Outcome measures
| Measure |
Overall Population
n=312 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
n=35 Participants
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
n=25 Participants
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
n=40 Participants
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
DAS28 by Duration of Treatment of Biological Agent
|
4.6 units on a scale
Standard Deviation 1.45
|
3.5 units on a scale
Standard Deviation 1.44
|
3.9 units on a scale
Standard Deviation 1.42
|
3.2 units on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*PtGA of disease activity; DAS28-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(10\*CRP+1) + 0.014\*PtGA. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.
Outcome measures
| Measure |
Overall Population
n=56 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
n=356 Participants
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs
|
4.8 units on a scale
Standard Deviation 1.76
|
4.3 units on a scale
Standard Deviation 1.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population
PGA of disease activity was measured on a 0 to 10 centimeter (cm) VAS, with 0 cm = no disease activity and 10 cm = extreme disease activity.
Outcome measures
| Measure |
Overall Population
n=802 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Physician's Global Assessment (PGA) of Disease Activity
|
4.2 cm
Standard Deviation 2.23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
PtGA of disease activity was measured on a 0 to 10 cm VAS, with 0 cm = very well controlled and 10 cm = very poorly controlled.
Outcome measures
| Measure |
Overall Population
n=801 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Patient's Global Assessment (PtGA) of Disease Activity
|
4.4 cm
Standard Deviation 2.30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
The HAQ consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from "no difficulty" to "unable to do", corresponding to scores from 0 to 3. HAQ total score = sum of each of the 20 items' scores, with a summary score ranging from 0 to 60, where higher score indicates greater disability.
Outcome measures
| Measure |
Overall Population
n=800 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
|
11.9 units on a scale
Standard Deviation 13.44
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.
Outcome measures
| Measure |
Overall Population
n=801 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Participant's Fatigue Assessment
|
3.7 cm
Standard Deviation 2.51
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (enrollment visit)Population: Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.
Participants scored the intensity of pain produced by RA on 10 cm VAS from 0 = no pain to 10 = extreme pain.
Outcome measures
| Measure |
Overall Population
n=801 Participants
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
Duration of Biological Treatment >=3 to <6 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=3 to \<6 months.
|
Duration of Biological Treatment >=6 to <12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=6 to \<12 months.
|
Duration of Biological Treatment >=12 Months
Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment \>=12 months.
|
|---|---|---|---|---|
|
Participant's Pain Assessment
|
4.2 cm
Standard Deviation 2.44
|
—
|
—
|
—
|
Adverse Events
Overall Population
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Population
n=802 participants at risk
Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
|
|---|---|
|
Hepatobiliary disorders
Abnormal liver function
|
0.12%
1/802 • Day 1 (enrollment visit)
Overall population
|
|
Musculoskeletal and connective tissue disorders
Amyosthenia
|
0.12%
1/802 • Day 1 (enrollment visit)
Overall population
|
|
Skin and subcutaneous tissue disorders
Erythra
|
0.12%
1/802 • Day 1 (enrollment visit)
Overall population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.12%
1/802 • Day 1 (enrollment visit)
Overall population
|
|
Gastrointestinal disorders
Dry mouth
|
0.12%
1/802 • Day 1 (enrollment visit)
Overall population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER