Trial Outcomes & Findings for An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis (NCT NCT00896168)

NCT ID: NCT00896168

Last Updated: 2013-09-13

Results Overview

ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire \[HAQ\]) and C-reactive protein (CRP).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 234 participants
• Primary outcome timeframe: Week 26
• Results posted on: 2013-09-13

Participant Flow

Participant milestones

Measure	Infliximab + Methotrexate (Moderate Rheumatoid Arthritis [RA]) Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activitiy score \[DAS\] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Overall Study STARTED	104	130
Overall Study COMPLETED	90	111
Overall Study NOT COMPLETED	14	19

Reasons for withdrawal

Measure	Infliximab + Methotrexate (Moderate Rheumatoid Arthritis [RA]) Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activitiy score \[DAS\] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Overall Study Adverse Event	4	7
Overall Study Treatment failure	8	10
Overall Study Lost to Follow-up	1	1
Overall Study Other	1	1

Baseline Characteristics

An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.	Total n=234 Participants Total of all reporting groups
Age Continuous	42.83 Years STANDARD_DEVIATION 12.05 • n=5 Participants	46.62 Years STANDARD_DEVIATION 11.39 • n=7 Participants	44.92 Years STANDARD_DEVIATION 11.84 • n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	116 Participants n=7 Participants	208 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 26

Population: Full analysis set (FAS) included participants who received at least 1 dose of study medication and had post efficacy data.

ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response	63.46 Percentage of participants	76.15 Percentage of participants

PRIMARY outcome

Timeframe: Week 26

Population: The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.

ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response	47.12 Percentage of participants	57.69 Percentage of participants

PRIMARY outcome

Timeframe: Week 26

Population: The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.

ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response	29.81 Percentage of participants	29.23 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.

Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative).

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Change From Baseline in Swollen Joints Count at Week 26 Baseline	4 Swollen joints Standard Deviation 3	11 Swollen joints Standard Deviation 7
Change From Baseline in Swollen Joints Count at Week 26 Change at Week 26	-2.6 Swollen joints Standard Deviation 3.4	-7.7 Swollen joints Standard Deviation 5.9

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.

Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe).

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Change From Baseline in Tender Joints Count at Week 26 Baseline	6 Tender joints Standard Deviation 4	15 Tender joints Standard Deviation 8
Change From Baseline in Tender Joints Count at Week 26 Change at Week 26	-4.0 Tender joints Standard Deviation 4.1	-10.6 Tender joints Standard Deviation 8.0

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.

Participant's pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain).

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26 Baseline	47 Units on a scale Standard Deviation 16	67 Units on a scale Standard Deviation 18
Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26 Change at Week 26	-26.8 Units on a scale Standard Deviation 21.9	-37.3 Units on a scale Standard Deviation 27.9

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.

Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using "0 mm=very good" to "100 mm=very poor" scale.

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Change From Baseline in Participants' Global Disease Assessment at Week 26 Baseline	49 Units on a scale Standard Deviation 17	68 Units on a scale Standard Deviation 17
Change From Baseline in Participants' Global Disease Assessment at Week 26 Change at Week 26	-28.3 Units on a scale Standard Deviation 23.3	-39.3 Units on a scale Standard Deviation 27.1

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.

Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using "0=no active RA" to "100=most serious active RA" scale.

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Change From Baseline in Physicians' Global Disease Assessment at Week 26 Baseline	46 Units on a scale Standard Deviation 17	67 Units on a scale Standard Deviation 18
Change From Baseline in Physicians' Global Disease Assessment at Week 26 Change at Week 26	-25.3 Units on a scale Standard Deviation 21.7	-36.4 Units on a scale Standard Deviation 23.1

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.

Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Change From Baseline in Duration of Morning Stiffness at Week 26 Baseline	44.73 Minutes Standard Deviation 61.97	102.58 Minutes Standard Deviation 144.36
Change From Baseline in Duration of Morning Stiffness at Week 26 Change at Week 26	-36.63 Minutes Standard Deviation 68.38	-77.12 Minutes Standard Deviation 84.73

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.

The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area.

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26 Baseline	0.9 Units on a scale Standard Deviation 0.6	1.3 Units on a scale Standard Deviation 0.8
Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26 Change at Week 26	-0.59 Units on a scale Standard Deviation 0.58	-0.83 Units on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. Here, 'N' signifies participants who were evaluated for this outcome measure.

CRP is a protein found in the blood, the levels of which rise in response to inflammation.

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=103 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=128 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Change From Baseline in C-Reactive Protein (CRP) at Week 26 Baseline	1.24 Milligram/Liter Standard Deviation 1.71	2.93 Milligram/Liter Standard Deviation 4.26
Change From Baseline in C-Reactive Protein (CRP) at Week 26 Change at Week 26	-0.54 Milligram/Liter Standard Deviation 1.52	-1.22 Milligram/Liter Standard Deviation 4.69

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.

ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation.

Outcome measures

Measure	Infliximab + Methotrexate (Moderate RA) n=104 Participants Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 Participants Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26 Baseline	24.45 Millimeter/1 hour Standard Deviation 16.62	51.34 Millimeter/1 hour Standard Deviation 28.66
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26 Change at Week 26	-2.19 Millimeter/1 hour Standard Deviation 17.82	-16.53 Millimeter/1 hour Standard Deviation 29.77

Adverse Events

Infliximab + Methotrexate (Moderate RA)

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Infliximab + Methotrexate (Severe RA)

Serious events: 2 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infliximab + Methotrexate (Moderate RA) n=104 participants at risk Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 participants at risk Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Immune system disorders Tuberculosis	0.00% 0/104 • Baseline up to Week 26	0.77% 1/130 • Baseline up to Week 26
Immune system disorders Fungal pneumonia	0.00% 0/104 • Baseline up to Week 26	0.77% 1/130 • Baseline up to Week 26
Immune system disorders Septicemia	0.96% 1/104 • Baseline up to Week 26	0.00% 0/130 • Baseline up to Week 26
Cardiac disorders Cardiac disorders	0.96% 1/104 • Baseline up to Week 26	0.00% 0/130 • Baseline up to Week 26

Other adverse events

Measure	Infliximab + Methotrexate (Moderate RA) n=104 participants at risk Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.	Infliximab + Methotrexate (Severe RA) n=130 participants at risk Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
Skin and subcutaneous tissue disorders Skin rash	0.96% 1/104 • Baseline up to Week 26	10.0% 13/130 • Baseline up to Week 26
Gastrointestinal disorders Abdominal pain	1.9% 2/104 • Baseline up to Week 26	3.1% 4/130 • Baseline up to Week 26
General disorders Fever	3.8% 4/104 • Baseline up to Week 26	7.7% 10/130 • Baseline up to Week 26
Cardiac disorders Hypertension	3.8% 4/104 • Baseline up to Week 26	2.3% 3/130 • Baseline up to Week 26
Blood and lymphatic system disorders Hypolekocytosis	3.8% 4/104 • Baseline up to Week 26	10.8% 14/130 • Baseline up to Week 26
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	27.9% 29/104 • Baseline up to Week 26	30.0% 39/130 • Baseline up to Week 26
Respiratory, thoracic and mediastinal disorders Cough	1.9% 2/104 • Baseline up to Week 26	3.1% 4/130 • Baseline up to Week 26
Respiratory, thoracic and mediastinal disorders Pharyngitis	0.96% 1/104 • Baseline up to Week 26	5.4% 7/130 • Baseline up to Week 26
Hepatobiliary disorders Hepatic function disnormal	50.0% 52/104 • Baseline up to Week 26	37.7% 49/130 • Baseline up to Week 26
Gastrointestinal disorders Nausea	3.8% 4/104 • Baseline up to Week 26	3.1% 4/130 • Baseline up to Week 26

Additional Information

Director of Medical Affairs

Xian-Janssen Pharmaceutical Ltd

Phone: (8610) 5821 8359

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60