Maraviroc in Rheumatoid Arthritis

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow:   Overall Study

	Maraviroc 150 mg BID (Pharmacokinetic [PK])	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (Proof-of-Concept [POC])	Placebo (POC)
STARTED	8	8	78	34
Treated	8	8	77	33
COMPLETED	7	8	55	19
NOT COMPLETED	1	0	23	15
Adverse Event	1	0	5	4
Lack of Efficacy	0	0	5	2
Randomized But Did Not Receive Treatment	0	0	1	1
Unknown	0	0	11	5
Withdrawal by Subject	0	0	1	3

Reporting Groups

	Description
Maraviroc 150 mg BID (PK)	150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of 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 (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.
Total	Total of all reporting groups

Baseline Measures

	Maraviroc 150 mg BID (PK)	Maraviroc 300 mg BID (PK)	Maraviroc 300 mg BID (POC)	Placebo (POC)	Total
Number of Participants   [units: participants]	8	8	77	33	126
Age, Customized   [units: Participants]
< 18 years	0	0	0	0	0
18 to 44 years	1	0	15	6	22
45 to 64 years	4	8	48	21	81
> = 65 years	3	0	14	6	23
Gender   [units: Participants]
Female	4	5	71	22	102
Male	4	3	6	11	24

1.  Primary:

American College of Rheumatology (ACR) 20% Responders at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:

ACR 20% Responders at Weeks 1, 2, 4, and 8   [ Time Frame: Weeks 1, 2, 4, and 8 ]

3.  Secondary:

ACR 50% Responders at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]

4.  Secondary:

ACR 70% Responders at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]

5.  Secondary:

Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

6.  Secondary:

Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

7.  Secondary:

Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

8.  Secondary:

Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

9.  Secondary:

Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

10.  Secondary:

Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

11.  Secondary:

Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

12.  Secondary:

Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline, Weeks 1, 2, 4, 8, and 12 ]

13.  Secondary:

Change From Baseline in Mean Orthostatic Blood Pressure (BP)   [ Time Frame: Baseline, 16 weeks ]

14.  Secondary:

Change From Baseline in Mean Heart Rate   [ Time Frame: Baseline, 16 weeks ]

15.  Secondary:

Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline   [ Time Frame: Baseline, 16 weeks ]

16.  Secondary:

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]).   [ Time Frame: Baseline, 16 weeks ]

17.  Secondary:

Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).   [ Time Frame: Baseline, 16 weeks ]

18.  Secondary:

Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline   [ Time Frame: Baseline, 16 weeks ]

19.  Secondary:

Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12   [ Time Frame: Baseline, Weeks 4 and 12 ]

20.  Secondary:

Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12   [ Time Frame: Baseline, Weeks 4 and 12 ]

21.  Secondary:

Number of Subjects With Withdrawal From Study Due to Lack of Efficacy   [ Time Frame: 16 weeks ]

22.  Secondary:

Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.   [ Time Frame: Weeks 1 to 12 ]

23.  Secondary:

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   [ Time Frame: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose) ]

24.  Secondary:

Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1   [ Time Frame: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose) ]

25.  Secondary:

Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1   [ Time Frame: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose) ]