Trial Outcomes & Findings for A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (NCT NCT01353859)
NCT ID: NCT01353859
Last Updated: 2014-06-06
Results Overview
Disease Activity Score using 28-Joint Count (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog scale \[VAS\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Week 24
Results posted on
2014-06-06
Participant Flow
Participant milestones
| Measure |
Tocilizumab + Methotrexate (MTX)
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (minimum dose 480 mg, maximum dose 800 mg), intravenously (IV), once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Tocilizumab + Methotrexate (MTX)
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (minimum dose 480 mg, maximum dose 800 mg), intravenously (IV), once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs
Baseline characteristics by cohort
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: ITT population: All participants randomized in the study who received administration of at least one dose of the study drug and who had the last week 24 assessment performed.
Disease Activity Score using 28-Joint Count (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog scale \[VAS\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.
Outcome measures
| Measure |
Tocilizumab + MTX
n=35 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Percentage of Participants Achieving Low Disease Activity Score
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24Population: ITT Population
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity; time to low disease activity was calculated as the time in weeks from the date of first infusion to the first achievement of DAS28 ≤3.2
Outcome measures
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Time to Achieve Low Disease Activity (DAS28 ≤3.2)
|
9.5 weeks
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: ITT Population
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement in DAS28 score was defined as a reduction of at least 1.2 units.
Outcome measures
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Percentage of Participants With a Clinically Significant Improvement in DAS28 Score
Week 4
|
87.2 percentage of participants
|
|
Percentage of Participants With a Clinically Significant Improvement in DAS28 Score
Week 8
|
91.9 percentage of participants
|
|
Percentage of Participants With a Clinically Significant Improvement in DAS28 Score
Week 12
|
94.7 percentage of participants
|
|
Percentage of Participants With a Clinically Significant Improvement in DAS28 Score
Week 16
|
97.3 percentage of participants
|
|
Percentage of Participants With a Clinically Significant Improvement in DAS28 Score
Week 20
|
97.3 percentage of participants
|
|
Percentage of Participants With a Clinically Significant Improvement in DAS28 Score
Week 24
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: ITT Population
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement is a reduction in DAS28 score of at least 1.2 units. Time to clinically significant improvement was determined in weeks from the date of first infusion to the date of first achievement of reduction of 1.2 units in DAS28.
Outcome measures
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Time to Clinically Significant Improvement in DAS28
|
12.5 weeks
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Remission was defined as DAS28 \<2.6.
Outcome measures
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
Baseline
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
Week 4
|
20.5 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
Week 8
|
36.8 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
Week 12
|
44.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
Week 16
|
59.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
Week 20
|
74.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
Week 24
|
82.1 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: ITT Population
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 remission was defined as DAS28 \<2.6. Time to achieve remission was calculated in weeks as the time from the date of first infusion to the date of first achieving remission.
Outcome measures
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Time to Achieve DAS28 Remission (DAS28 <2.6)
|
4.4 weeks
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Outcome measures
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Percentage of Participants With DAS28 <3.2 by Visit
Baseline
|
0.0 percentage of participants
|
|
Percentage of Participants With DAS28 <3.2 by Visit
Week 4
|
30.8 percentage of participants
|
|
Percentage of Participants With DAS28 <3.2 by Visit
Week 8
|
48.7 percentage of participants
|
|
Percentage of Participants With DAS28 <3.2 by Visit
Week 12
|
69.2 percentage of participants
|
|
Percentage of Participants With DAS28 <3.2 by Visit
Week 16
|
82.1 percentage of participants
|
|
Percentage of Participants With DAS28 <3.2 by Visit
Week 20
|
89.7 percentage of participants
|
|
Percentage of Participants With DAS28 <3.2 by Visit
Week 24
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population
ACR20/50/70 response was defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) as well as improvement in at least 3 of the 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the health assessment questionnaire \[HAQ\]); and acute phase response: C-reactive protein (CRP) or ESR.
Outcome measures
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response
ACR20
|
20 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response
ACR50
|
34 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response
ACR70
|
34 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
Erythrocyte Sedimentation rate was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.
Outcome measures
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Erythrocyte Sedimentation Rate
Baseline
|
48.1 mm/hr
Standard Deviation 26.1
|
|
Erythrocyte Sedimentation Rate
Week 4
|
10.7 mm/hr
Standard Deviation 13.5
|
|
Erythrocyte Sedimentation Rate
Week 8
|
9.1 mm/hr
Standard Deviation 10.5
|
|
Erythrocyte Sedimentation Rate
Week 12
|
6.3 mm/hr
Standard Deviation 4.3
|
|
Erythrocyte Sedimentation Rate
Week 16
|
8.3 mm/hr
Standard Deviation 8.3
|
|
Erythrocyte Sedimentation Rate
Week 20
|
6.6 mm/hr
Standard Deviation 4.3
|
|
Erythrocyte Sedimentation Rate
Week 24
|
5.8 mm/hr
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12,16, 20, and 24Population: ITT Population
CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.
Outcome measures
| Measure |
Tocilizumab + MTX
n=39 Participants
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
C-Reactive Protein Levels
Week 8
|
0.8 mg/L
Standard Deviation 1.9
|
|
C-Reactive Protein Levels
Baseline
|
17.6 mg/L
Standard Deviation 21.6
|
|
C-Reactive Protein Levels
Week 4
|
2.1 mg/L
Standard Deviation 8.5
|
|
C-Reactive Protein Levels
Week 12
|
0.5 mg/L
Standard Deviation 1.0
|
|
C-Reactive Protein Levels
Week 16
|
1.2 mg/L
Standard Deviation 4.4
|
|
C-Reactive Protein Levels
Week 20
|
1.0 mg/L
Standard Deviation 2.6
|
|
C-Reactive Protein Levels
Week 24
|
0.4 mg/L
Standard Deviation 0.3
|
Adverse Events
Tocilizumab + MTX
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tocilizumab + MTX
n=39 participants at risk
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Infections and infestations
Sepsis
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Infections and infestations
Pulmonary tuberculosis
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
Other adverse events
| Measure |
Tocilizumab + MTX
n=39 participants at risk
Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
2/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
3/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.1%
2/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Gastrointestinal disorders
Odynophagia
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Gastrointestinal disorders
Stomatitis
|
12.8%
5/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
General disorders
Chills
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
General disorders
Fatigue
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
General disorders
Fever
|
5.1%
2/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
General disorders
Injection site ecchymosis
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
General disorders
Injection site haematoma
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
General disorders
Injection site pain
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
General disorders
Pain
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Investigations
Hepatic enzyme increased
|
30.8%
12/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
23.1%
9/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.1%
2/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
7.7%
3/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Infections and infestations
Fungal infection
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Infections and infestations
Herpes virus infection
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Infections and infestations
Lobar pneumonia
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Renal and urinary disorders
Azotaemia
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Nervous system disorders
Headache
|
7.7%
3/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.1%
2/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Vascular disorders
Hypertension
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Reproductive system and breast disorders
Pelvic inflammatory disease
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.5%
8/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
7.7%
3/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Pain ankle
|
12.8%
5/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
6/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
2.6%
1/39 • Adverse events were recorded from the day of baseline evaluation until the end of study at Week 24.
|
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 after the first publication or presentation that involves the overall study. 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