Trial Outcomes & Findings for Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy (NCT NCT01248780)
NCT ID: NCT01248780
Last Updated: 2013-09-06
Results Overview
ACR 20 response is defined as \>= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
264 participants
Primary outcome timeframe
Week 14
Results posted on
2013-09-06
Participant Flow
In this trial, 264 participants were randomly assigned to the 2 treatment arms.
Participant milestones
| Measure |
Group I: Placebo + MTX -> Golimumab 50 mg + MTX
Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Group II: Golimumab 50 mg + MTX
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
132
|
|
Overall Study
COMPLETED
|
123
|
117
|
|
Overall Study
NOT COMPLETED
|
9
|
15
|
Reasons for withdrawal
| Measure |
Group I: Placebo + MTX -> Golimumab 50 mg + MTX
Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Group II: Golimumab 50 mg + MTX
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
7
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Not treated
|
0
|
1
|
Baseline Characteristics
Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
Group I: Placebo + MTX -> Golimumab 50 mg + MTX
n=132 Participants
Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Group II: Golimumab 50 mg + MTX
n=132 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.7 years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 11.46 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.
ACR 20 response is defined as \>= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.
Outcome measures
| Measure |
Group I: Placebo + MTX
n=132 Participants
Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Group II: Golimumab 50 mg + MTX
n=132 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
|---|---|---|
|
American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14
|
21 Number of participants
|
54 Number of participants
|
SECONDARY outcome
Timeframe: Week 14Population: Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.
DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessments of disease activity. A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A DAS28 (using CRP) responder is defined as a participant with a DAS28 response of "Good" or "Moderate" at Week 14. A "Good" response is defined as a patient with a DAS28 score of \<= 3.2 at Week 14 with improvement from Baseline in DAS28 score of \> 1.2. A "Moderate" response was defined as a patient with DAS28 score of \>3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of \>0.6 to \>1.2 The table below shows the number of participants in each treatment group who were DAS28 responders at Week 14.
Outcome measures
| Measure |
Group I: Placebo + MTX
n=132 Participants
Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Group II: Golimumab 50 mg + MTX
n=132 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
|---|---|---|
|
Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein)
|
40 Number of participants
|
86 Number of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.
ACR 20 response is defined as \>= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.
Outcome measures
| Measure |
Group I: Placebo + MTX
n=132 Participants
Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Group II: Golimumab 50 mg + MTX
n=132 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
|---|---|---|
|
American College of Rheumatology 20 Response, Using CRP, at Week 24
|
21 Number of participants
|
56 Number of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.
The HAQ assesses the degree of difficulty a person has in accomplishing tasks in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The full range of the HAQ scale is 0-24 with 0 being the best possible outcome. The HAQ score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3 with 0 being the best possible outcome (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, or 3=unable to do). The mean change from baseline at Week 24 in HAQ score is provided below for each treatment group. A negative change from baseline is indicative of a lesser degree of difficulty in accomplishing tasks assessed in the HAQ.
Outcome measures
| Measure |
Group I: Placebo + MTX
n=132 Participants
Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Group II: Golimumab 50 mg + MTX
n=132 Participants
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
|---|---|---|
|
HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline
|
0.1525 Scores on a scale
Standard Deviation 0.69164
|
-0.2623 Scores on a scale
Standard Deviation 0.56767
|
Adverse Events
Group I: Placebo + MTX -> Golimumab 50 mg + MTX
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Group II: Golimumab 50 mg + MTX
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I: Placebo + MTX -> Golimumab 50 mg + MTX
n=128 participants at risk
Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escaped to receive golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48; or placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48. In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Group II: Golimumab 50 mg + MTX
n=131 participants at risk
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
|---|---|---|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.76%
1/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
1.5%
2/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.78%
1/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.00%
0/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Infections and infestations
Lung Infection
|
0.78%
1/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.00%
0/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.76%
1/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.76%
1/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.76%
1/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.76%
1/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Investigations
White Blood Cell Count Decreased
|
0.78%
1/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.00%
0/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.76%
1/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.78%
1/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
0.00%
0/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
Other adverse events
| Measure |
Group I: Placebo + MTX -> Golimumab 50 mg + MTX
n=128 participants at risk
Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escaped to receive golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48; or placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48. In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
Group II: Golimumab 50 mg + MTX
n=131 participants at risk
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (\>= 7.5 mg/week and \<= 20 mg/week).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
8/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
1.5%
2/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
25.0%
32/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
19.1%
25/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
|
Investigations
Liver Function Test Abnormal
|
5.5%
7/128 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
6.1%
8/131 • Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
|
Additional Information
Associate Director, Clinical Research
Janssen Research & Development
Phone: 610-500-3369
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60