Trial Outcomes & Findings for Maraviroc in Rheumatoid Arthritis (NCT NCT00427934)
NCT ID: NCT00427934
Last Updated: 2014-11-05
Results Overview
A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient's Assessment of Arthritis Pain (Visual Analogue Scale \[VAS\]), Patient's Global Assessment of Arthritis (VAS), Physician's Global Assessment of Arthritis (Categorical), Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-Reactive Protein (CRP).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
128 participants
Primary outcome timeframe
Week 12
Results posted on
2014-11-05
Participant Flow
Participant milestones
| Measure |
Maraviroc 150 mg BID (Pharmacokinetic [PK])
150 mg tablet was administered by mouth twice a day (BID) for 4 weeks with stable weekly doses of methotrexate (MTX).
|
Maraviroc 300 mg BID (PK)
300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (Proof-of-Concept [POC])
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
78
|
34
|
|
Overall Study
Treated
|
8
|
8
|
77
|
33
|
|
Overall Study
COMPLETED
|
7
|
8
|
55
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
23
|
15
|
Reasons for withdrawal
| Measure |
Maraviroc 150 mg BID (Pharmacokinetic [PK])
150 mg tablet was administered by mouth twice a day (BID) for 4 weeks with stable weekly doses of methotrexate (MTX).
|
Maraviroc 300 mg BID (PK)
300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (Proof-of-Concept [POC])
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
5
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
5
|
2
|
|
Overall Study
Randomized But Did Not Receive Treatment
|
0
|
0
|
1
|
1
|
|
Overall Study
Other
|
0
|
0
|
11
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
3
|
Baseline Characteristics
Maraviroc in Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Maraviroc 150 mg BID (PK)
n=8 Participants
150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (PK)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
18 to 44 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Customized
45 to 64 years
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Age, Customized
> = 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) was defined as an intent-to-treat analysis set that included all subjects randomized to treatment who had taken at least 1 dose of study medication. Missing values were imputed by the method of last observation carried forward (LOCF).
A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient's Assessment of Arthritis Pain (Visual Analogue Scale \[VAS\]), Patient's Global Assessment of Arthritis (VAS), Physician's Global Assessment of Arthritis (Categorical), Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-Reactive Protein (CRP).
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
American College of Rheumatology (ACR) 20% Responders at Week 12
|
21 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, and 8Population: FAS. Missing values were imputed by the method of LOCF.
A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 20% data were collected, but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
ACR 20% Responders at Weeks 1, 2, 4, and 8
Week 1
|
8 Participants
|
4 Participants
|
—
|
—
|
|
ACR 20% Responders at Weeks 1, 2, 4, and 8
Week 2
|
12 Participants
|
5 Participants
|
—
|
—
|
|
ACR 20% Responders at Weeks 1, 2, 4, and 8
Week 4
|
21 Participants
|
8 Participants
|
—
|
—
|
|
ACR 20% Responders at Weeks 1, 2, 4, and 8
Week 8
|
23 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: FAS. Missing values were imputed by the method of LOCF.
A subject was an ACR 50 responder if: the counts for both tender and swollen joints had reduced by 50% or more from baseline; and 3 out of the following 5 assessments showed reduction of 50% or more from baseline assessment: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 50% data were collected, but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
ACR 50% Responders at Weeks 1, 2, 4, 8, and 12
Week 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
ACR 50% Responders at Weeks 1, 2, 4, 8, and 12
Week 2
|
2 Participants
|
0 Participants
|
—
|
—
|
|
ACR 50% Responders at Weeks 1, 2, 4, 8, and 12
Week 4
|
2 Participants
|
2 Participants
|
—
|
—
|
|
ACR 50% Responders at Weeks 1, 2, 4, 8, and 12
Week 8
|
6 Participants
|
3 Participants
|
—
|
—
|
|
ACR 50% Responders at Weeks 1, 2, 4, 8, and 12
Week 12
|
8 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, and 12Population: FAS. Missing values were imputed by the method of LOCF.
A subject was an ACR 70 responder if: the counts for both tender and swollen joints had reduced by 70% or more from baseline; and 3 out of the following 5 assessments showed reduction of 70% or more from baseline assessment: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 70% data were collected, but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
ACR 70% Responders at Weeks 1, 2, 4, 8, and 12
Week 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
ACR 70% Responders at Weeks 1, 2, 4, 8, and 12
Week 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
ACR 70% Responders at Weeks 1, 2, 4, 8, and 12
Week 4
|
0 Participants
|
1 Participants
|
—
|
—
|
|
ACR 70% Responders at Weeks 1, 2, 4, 8, and 12
Week 8
|
2 Participants
|
0 Participants
|
—
|
—
|
|
ACR 70% Responders at Weeks 1, 2, 4, 8, and 12
Week 12
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12Population: FAS. Missing values were imputed by the method of LOCF.
Change from baseline at each visit was analyzed for tender/painful joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, metacarpophalangeal joints (MCP), proximal interphalangeal joints (PIP), and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 tender/painful joint count data were collected, but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12
Week 1
|
-0.81 joint count
Standard Error 0.68
|
-1.91 joint count
Standard Error 0.96
|
—
|
—
|
|
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12
Week 2
|
-2.08 joint count
Standard Error 0.76
|
-2.38 joint count
Standard Error 1.08
|
—
|
—
|
|
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12
Week 4
|
-4.00 joint count
Standard Error 0.84
|
-4.01 joint count
Standard Error 1.20
|
—
|
—
|
|
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12
Week 8
|
-4.85 joint count
Standard Error 0.85
|
-3.24 joint count
Standard Error 1.21
|
—
|
—
|
|
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12
Week 12
|
-4.89 joint count
Standard Error 0.84
|
-3.41 joint count
Standard Error 1.19
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12Population: FAS. Missing values were imputed by the method of LOCF.
Change from baseline at each visit was analyzed for swollen joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, MCP joints, PIP joints, and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 swollen joint count data were collected, but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12
Week 1
|
-1.39 joint count
Standard Error 0.49
|
-1.07 joint count
Standard Error 0.70
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12
Week 2
|
-2.25 joint count
Standard Error 0.61
|
-2.51 joint count
Standard Error 0.87
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12
Week 4
|
-3.93 joint count
Standard Error 0.54
|
-4.08 joint count
Standard Error 0.77
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12
Week 8
|
-4.48 joint count
Standard Error 0.62
|
-3.03 joint count
Standard Error 0.88
|
—
|
—
|
|
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12
Week 12
|
-3.48 joint count
Standard Error 0.66
|
-3.43 joint count
Standard Error 0.95
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12Population: FAS. Missing values were imputed by the method of LOCF.
The severity of arthritis was scored by the subject between 0 (no pain) and 100 (most severe pain) on a 100 mm VAS. Change from baseline at each visit was analyzed for Patient's Assessment of Arthritis Pain. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Assessment of Arthritis Pain data were collected, but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 1
|
-3.96 scores on scale
Standard Error 2.18
|
-3.62 scores on scale
Standard Error 3.10
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 2
|
-8.46 scores on scale
Standard Error 2.65
|
-3.20 scores on scale
Standard Error 3.77
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 4
|
-8.35 scores on scale
Standard Error 2.70
|
-9.08 scores on scale
Standard Error 3.85
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 8
|
-10.30 scores on scale
Standard Error 2.98
|
-8.67 scores on scale
Standard Error 4.24
|
—
|
—
|
|
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 12
|
-8.30 scores on scale
Standard Error 2.85
|
-6.09 scores on scale
Standard Error 4.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12Population: FAS. Missing values were imputed by the method of LOCF.
Subjects answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Subjects responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly. Change from baseline at each visit was analyzed for Patient's Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Global Assessment of Arthritis Pain data were collected, but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=76 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 1
|
-4.70 scores on scale
Standard Error 2.22
|
-2.34 scores on scale
Standard Error 3.13
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 2
|
-8.85 scores on scale
Standard Error 2.48
|
-4.88 scores on scale
Standard Error 3.49
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 4
|
-10.00 scores on scale
Standard Error 2.74
|
-9.02 scores on scale
Standard Error 3.86
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 8
|
-11.12 scores on scale
Standard Error 2.93
|
-3.44 scores on scale
Standard Error 4.13
|
—
|
—
|
|
Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 12
|
-8.55 scores on scale
Standard Error 2.88
|
-6.78 scores on scale
Standard Error 4.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12Population: FAS. Missing values were imputed by the method of LOCF.
Physician's evaluation based on subject's disease signs, functional capacity and physical exam. Response recorded using 5-point scale: 1=Very Good, 2=Good, 3=Fair, 4=Poor and 5=Very Poor. Change from baseline at each visit was analyzed for Physician's Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy thus Week 16 Physician's Global Assessment of Arthritis Pain data were collected but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=75 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=32 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 1
|
-0.30 scores on scale
Standard Error 0.08
|
-0.22 scores on scale
Standard Error 0.11
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 2
|
-0.44 scores on scale
Standard Error 0.09
|
-0.39 scores on scale
Standard Error 0.12
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 4
|
-0.49 scores on scale
Standard Error 0.10
|
-0.44 scores on scale
Standard Error 0.13
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 8
|
-0.63 scores on scale
Standard Error 0.10
|
-0.37 scores on scale
Standard Error 0.14
|
—
|
—
|
|
Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
Week 12
|
-0.49 scores on scale
Standard Error 0.11
|
-0.36 scores on scale
Standard Error 0.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12Population: FAS.
HAQ-DI assesses degree of difficulty experienced in daily activity categories (dressing/grooming, arising, eating, walking, hygiene, reach, grip and other activities) over the past week. There are 20 questions and difficulty is scored from 0 (none), 1 (some), 2 (much) and 3 (unable to do). Scores were then averaged to give the disability index (scale of 0 to 3). Change from baseline at each visit was analyzed. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 HAQ-DI data were collected but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=31 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12
Week 1
|
-0.08 scores on scale
Standard Error 0.05
|
-0.03 scores on scale
Standard Error 0.07
|
—
|
—
|
|
Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12
Week 2
|
-0.22 scores on scale
Standard Error 0.06
|
-0.04 scores on scale
Standard Error 0.08
|
—
|
—
|
|
Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12
Week 4
|
-0.24 scores on scale
Standard Error 0.06
|
-0.18 scores on scale
Standard Error 0.09
|
—
|
—
|
|
Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12
Week 8
|
-0.25 scores on scale
Standard Error 0.07
|
-0.03 scores on scale
Standard Error 0.10
|
—
|
—
|
|
Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12
Week 12
|
-0.18 scores on scale
Standard Error 0.08
|
-0.06 scores on scale
Standard Error 0.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12Population: FAS. Missing values were imputed by the method of LOCF.
Change from baseline at each visit were analyzed for CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 CRP data were collected, but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=73 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=31 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12
Week 1
|
1.20 mg/L
Standard Error 1.87
|
3.40 mg/L
Standard Error 2.67
|
—
|
—
|
|
Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12
Week 2
|
3.14 mg/L
Standard Error 2.06
|
1.81 mg/L
Standard Error 2.93
|
—
|
—
|
|
Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12
Week 4
|
3.36 mg/L
Standard Error 2.34
|
-1.30 mg/L
Standard Error 3.33
|
—
|
—
|
|
Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12
Week 8
|
2.33 mg/L
Standard Error 2.10
|
-1.14 mg/L
Standard Error 2.98
|
—
|
—
|
|
Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12
Week 12
|
2.35 mg/L
Standard Error 2.26
|
1.93 mg/L
Standard Error 3.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 4, 8, and 12Population: FAS. Missing values were imputed by the method of LOCF.
DAS28-4 (CRP) was calculated using the following formula: DAS28- 4(CRP) = 0.56 √28 Tender Joint Count + 0.28 √28 Swollen Joint Count + 0.36\*natural logarithm(CRP + 1) + 0.014\*Patient Global Assessment + 0.96. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at each visit was analyzed for DAS28-4 (CRP). The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 DAS28-4 (CRP) data were collected, but not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=72 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=31 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12
Week 1
|
-0.23 mg/L
Standard Error 0.09
|
-0.17 mg/L
Standard Error 0.13
|
—
|
—
|
|
Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12
Week 2
|
-0.41 mg/L
Standard Error 0.12
|
-0.33 mg/L
Standard Error 0.17
|
—
|
—
|
|
Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12
Week 4
|
-0.64 mg/L
Standard Error 0.14
|
-0.65 mg/L
Standard Error 0.19
|
—
|
—
|
|
Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12
Week 8
|
-0.82 mg/L
Standard Error 0.15
|
-0.51 mg/L
Standard Error 0.21
|
—
|
—
|
|
Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12
Week 12
|
-0.73 mg/L
Standard Error 0.16
|
-0.63 mg/L
Standard Error 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: FAS
Supine BP was recorded after 5 minutes lying down; subjects then sat for 2 minutes then stood for 2 minutes and standing BP was recorded. Orthostatic BP = either a systolic BP drop \> 20 mmHg, or diastolic BP drop \> 10 mmHg and/or drop in systolic BP \< 90 mmHg. If a subject met the orthostatic criteria, they were required to complete 2 additional readings to provide a triplicate reading. The means of replicate BP values were used in the analysis. Baseline = the latest non-missing value from a range of pre-treatment visits. Change from baseline to Week 16 was analyzed for orthostatic BP.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=8 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Orthostatic Blood Pressure (BP)
Standing Systolic BP
|
20.9 mmHg
Standard Deviation 13.18
|
18.0 mmHg
Standard Deviation 7.71
|
17.8 mmHg
Standard Deviation 11.25
|
17.5 mmHg
Standard Deviation 12.36
|
|
Change From Baseline in Mean Orthostatic Blood Pressure (BP)
Supine Systolic BP
|
20.9 mmHg
Standard Deviation 13.58
|
18.3 mmHg
Standard Deviation 9.51
|
17.5 mmHg
Standard Deviation 13.86
|
18.0 mmHg
Standard Deviation 11.12
|
|
Change From Baseline in Mean Orthostatic Blood Pressure (BP)
Standing Diastolic BP
|
13.0 mmHg
Standard Deviation 4.97
|
8.3 mmHg
Standard Deviation 5.65
|
11.7 mmHg
Standard Deviation 6.98
|
11.5 mmHg
Standard Deviation 5.15
|
|
Change From Baseline in Mean Orthostatic Blood Pressure (BP)
Supine Diastolic BP
|
10.3 mmHg
Standard Deviation 7.94
|
10.9 mmHg
Standard Deviation 5.08
|
12.2 mmHg
Standard Deviation 8.14
|
10.8 mmHg
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: FAS
Heart rate = standing and supine at the same time the orthostatic BP measurements were obtained. Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were not used.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=8 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Heart Rate
Standing Heart Rate
|
14.6 beats per minute (bpm)
Standard Deviation 6.73
|
8.1 beats per minute (bpm)
Standard Deviation 3.64
|
11.8 beats per minute (bpm)
Standard Deviation 6.91
|
11.4 beats per minute (bpm)
Standard Deviation 8.13
|
|
Change From Baseline in Mean Heart Rate
Supine Heart Rate
|
15.0 beats per minute (bpm)
Standard Deviation 8.28
|
10.4 beats per minute (bpm)
Standard Deviation 4.56
|
11.6 beats per minute (bpm)
Standard Deviation 6.06
|
9.2 beats per minute (bpm)
Standard Deviation 6.16
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: FAS
Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Maximum increase from baseline in supine and standing systolic BP was \> = 30 mmHg, and maximum increase from baseline in supine and standing diastolic BP was \> = 20 mmHg.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=8 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline
Maximum Increase in Supine Systolic BP
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline
Maximum Increase in Standing Systolic BP
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline
Maximum Increase in Supine Diastolic BP
|
1 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline
Maximum Increase in Standing Diastolic BP
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: FAS
Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used. QTc interval was not measured for the PK populations.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=8 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).
RR Interval
|
137.0 msec
Standard Deviation 79.18
|
114.3 msec
Standard Deviation 63.38
|
140.0 msec
Standard Deviation 70.81
|
117.6 msec
Standard Deviation 48.26
|
|
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).
PR Interval
|
19.7 msec
Standard Deviation 7.13
|
13.0 msec
Standard Deviation 6.93
|
16.2 msec
Standard Deviation 8.00
|
15.4 msec
Standard Deviation 10.47
|
|
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).
QRS Complex
|
7.6 msec
Standard Deviation 4.75
|
7.3 msec
Standard Deviation 4.89
|
11.3 msec
Standard Deviation 6.56
|
10.2 msec
Standard Deviation 5.35
|
|
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).
QT Interval
|
35.0 msec
Standard Deviation 19.47
|
22.5 msec
Standard Deviation 10.67
|
31.9 msec
Standard Deviation 18.74
|
28.7 msec
Standard Deviation 13.97
|
|
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).
QTc Interval
|
0 msec
Standard Deviation 0
|
0 msec
Standard Deviation 0
|
19.6 msec
Standard Deviation 17.69
|
20.3 msec
Standard Deviation 12.75
|
|
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).
QTcB Interval
|
23.1 msec
Standard Deviation 19.70
|
23.3 msec
Standard Deviation 9.55
|
27.9 msec
Standard Deviation 18.47
|
30.2 msec
Standard Deviation 23.88
|
|
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).
QTcF Interval
|
22.9 msec
Standard Deviation 19.64
|
17.3 msec
Standard Deviation 7.16
|
28.3 msec
Standard Deviation 18.77
|
29.8 msec
Standard Deviation 22.20
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: FAS
Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=8 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).
|
11.2 bpm
Standard Deviation 5.82
|
8.8 bpm
Standard Deviation 5.76
|
12.0 bpm
Standard Deviation 6.40
|
10.5 bpm
Standard Deviation 4.91
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: FAS
Maximum QTcB, QTcF, and QTc intervals were defined as 450 to \< 480 msec, 480 to \< 500 msec, or \> = 500 msec.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=8 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTc Interval 450 to < 480 msec
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTc Interval 480 to < 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTc Interval > = 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTcB Interval 450 to < 480 msec
|
1 Participants
|
3 Participants
|
13 Participants
|
8 Participants
|
|
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTcB Interval 480 to < 500 msec
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTcB Interval > = 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTcF Interval 450 to < 480 msec
|
0 Participants
|
2 Participants
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTcF Interval 480 to < 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTcF Interval > = 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4 and 12Population: FAS
The SF-36 v.2 (Acute version) is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (physical component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=69 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=30 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12
Week 4
|
4.33 scores on a scale
Standard Error 0.89
|
3.76 scores on a scale
Standard Error 1.25
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12
Week 12
|
3.14 scores on a scale
Standard Error 1.04
|
4.81 scores on a scale
Standard Error 1.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4 and 12Population: FAS
The SF-36 v.2 (Acute version) \[12\] is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (mental component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=69 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=30 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12
Week 4
|
1.42 scores on a scale
Standard Error 1.25
|
0.72 scores on a scale
Standard Error 1.75
|
—
|
—
|
|
Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12
Week 12
|
1.17 scores on a scale
Standard Error 1.41
|
0.61 scores on a scale
Standard Error 2.25
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: FAS
Withdrawal is the total number of withdrawals from the study. Withdrawal due to lack of efficacy was collected based on the investigator's judgement.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Number of Subjects With Withdrawal From Study Due to Lack of Efficacy
Overall Withdrawal
|
22 participants
|
14 participants
|
—
|
—
|
|
Number of Subjects With Withdrawal From Study Due to Lack of Efficacy
Withdrawal due to Lack of Efficacy
|
5 participants
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 to 12Population: FAS
Withdrawal due to lack of efficacy was collected based on the investigator's judgement. Time to withdrawal was measured by the probability that a subject did not withdraw due to lack of efficacy by a particular visit. This was a statistical estimate (Kaplan-Meier Survival Analysis) of the probability that a participant would not withdraw due to lack of efficacy.
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=77 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.
Week 8 (n=69, 31)
|
0.99 proportion
|
1.00 proportion
|
—
|
—
|
|
Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.
Week 12 (n=58, 21)
|
0.93 proportion
|
0.92 proportion
|
—
|
—
|
|
Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.
Week 1 (n=77, 33)
|
1.00 proportion
|
1.00 proportion
|
—
|
—
|
|
Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.
Week 2 (n=77, 32)
|
1.00 proportion
|
1.00 proportion
|
—
|
—
|
|
Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.
Week 4 (n=76, 32)
|
1.00 proportion
|
1.00 proportion
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)Population: All available PK data from the Safety/PK Component were included.
Effect of maraviroc on the PK of MTX (comparison of AUC0-4 of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=8 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1
Plasma MTX (Screening)
|
909.4 ng.hr/mL
Standard Deviation 422.37
|
888.9 ng.hr/mL
Standard Deviation 249.51
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1
Plasma MTX (Week 1)
|
1045.6 ng.hr/mL
Standard Deviation 329.93
|
844.8 ng.hr/mL
Standard Deviation 273.92
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1
Plasma Maraviroc (Week 1)
|
451.6 ng.hr/mL
Standard Deviation 247.33
|
1106.8 ng.hr/mL
Standard Deviation 1029.60
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)Population: All available PK data from the Safety/PK Component were included.
Effect of maraviroc on the PK of MTX (comparison of Cmax of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=8 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1
Plasma MTX (Screening)
|
338.7 ng/mL
Standard Deviation 143.94
|
352.1 ng/mL
Standard Deviation 115.72
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1
Plasma MTX (Week 1)
|
403.8 ng/mL
Standard Deviation 97.46
|
322.8 ng/mL
Standard Deviation 104.20
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1
Plasma Maraviroc (Week 1)
|
199.59 ng/mL
Standard Deviation 115.603
|
461.03 ng/mL
Standard Deviation 365.715
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)Population: All available PK data from the Safety/PK Component were included.
PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Outcome measures
| Measure |
Maraviroc 300 mg BID (POC)
n=8 Participants
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=8 Participants
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1
Plasma MTX (Screening)
|
2.000 hr
Interval 1.0 to 3.0
|
1.000 hr
Interval 1.0 to 3.0
|
—
|
—
|
|
Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1
Plasma MTX (Week 1)
|
1.000 hr
Interval 0.5 to 2.0
|
1.500 hr
Interval 0.5 to 2.0
|
—
|
—
|
|
Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1
Plasma Maraviroc (Week 1)
|
2.000 hr
Interval 0.5 to 3.0
|
2.500 hr
Interval 1.0 to 4.0
|
—
|
—
|
Adverse Events
Maraviroc 150 mg BID (PK)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Maraviroc 300 mg BID (PK)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Maraviroc 300 mg BID (POC)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo (POC)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maraviroc 150 mg BID (PK)
n=8 participants at risk
150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (PK)
n=8 participants at risk
300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
|
Maraviroc 300 mg BID (POC)
n=77 participants at risk
300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
Placebo (POC)
n=33 participants at risk
Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Endocrine disorders
Goitre
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
3.0%
1/33
|
|
Eye disorders
Diplopia
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Eye disorders
Glaucoma
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Eye disorders
Vision blurred
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Eye disorders
Visual impairment
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
0.00%
0/8
|
7.8%
6/77
|
0.00%
0/33
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
6.1%
2/33
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8
|
12.5%
1/8
|
1.3%
1/77
|
3.0%
1/33
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8
|
0.00%
0/8
|
2.6%
2/77
|
0.00%
0/33
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8
|
0.00%
0/8
|
5.2%
4/77
|
0.00%
0/33
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
General disorders
Chest pain
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
General disorders
Chills
|
0.00%
0/8
|
0.00%
0/8
|
2.6%
2/77
|
3.0%
1/33
|
|
General disorders
Fatigue
|
12.5%
1/8
|
0.00%
0/8
|
3.9%
3/77
|
0.00%
0/33
|
|
General disorders
Feeling cold
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
General disorders
Irritability
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
General disorders
Oedema peripheral
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
6.1%
2/33
|
|
General disorders
Pyrexia
|
0.00%
0/8
|
0.00%
0/8
|
2.6%
2/77
|
0.00%
0/33
|
|
General disorders
Ulcer
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Infections and infestations
Influenza
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
6.1%
2/33
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/8
|
0.00%
0/8
|
2.6%
2/77
|
0.00%
0/33
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8
|
12.5%
1/8
|
3.9%
3/77
|
0.00%
0/33
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
3.0%
1/33
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8
|
12.5%
1/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/8
|
0.00%
0/8
|
3.9%
3/77
|
24.2%
8/33
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
0.00%
0/8
|
2.6%
2/77
|
3.0%
1/33
|
|
Nervous system disorders
Headache
|
0.00%
0/8
|
0.00%
0/8
|
2.6%
2/77
|
3.0%
1/33
|
|
Nervous system disorders
Sciatica
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Psychiatric disorders
Depression
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Psychiatric disorders
Hallucination, olfactory
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8
|
12.5%
1/8
|
1.3%
1/77
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8
|
12.5%
1/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/77
|
3.0%
1/33
|
|
Vascular disorders
Hot flush
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Vascular disorders
Hypotension
|
0.00%
0/8
|
0.00%
0/8
|
1.3%
1/77
|
0.00%
0/33
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8
|
0.00%
0/8
|
2.6%
2/77
|
0.00%
0/33
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/77
|
0.00%
0/33
|
|
General disorders
Influenza like illness
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/77
|
0.00%
0/33
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/77
|
0.00%
0/33
|
|
Injury, poisoning and procedural complications
Back injury
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/77
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/77
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/77
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/77
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/77
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/77
|
0.00%
0/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER