Arthritis, RheumatoidPhase 2NCT00427934
Maraviroc in Rheumatoid Arthritis
A Phase 2 study testing Maraviroc in people with Arthritis, Rheumatoid, run by Pfizer at 44 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Maraviroc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 44 sitesin 9 countries
- Study dates
- Feb 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be legal age of consent
- Must have active rheumatoid arthritis based upon the American College of Rheumatology (ACR) 1987 (Revised Criteria); minimum disease criteria required for entry into the efficacy component of the study
- Must meet ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III
- Must be receiving methotrexate for at least 12 weeks duration and on a stable dose for 4 weeks.
Who cannot join
- Diagnosed with any other inflammatory arthritis or a secondary non-inflammatory arthritis that would interfere with disease activity assessments.
- Subject receiving prior treatment with certain medications for rheumatoid arthritis
- Tuberculosis and/or a positive tuberculin reaction
- Significant trauma or major surgery within 2 months
- History of alcohol and/or drug abuse outside of a defined period of abstinence
- History of or a finding at screening of postural hypotension
Show all 14Show fewer
- Any condition that would affect the oral absorption of the drug
- History of cancer and in remission less than 3 years or Grade III-IV congestive heart failure
- Having an infection of human immunodeficiency virus (HIV), Hepatitis B or C or evidence of any active infection
- Abnormalities of clinical or laboratory assessments completed at the screening visit such as elevated liver enzymes, decreased hemoglobin or an abnormal ECG
- Having a positive chemokine receptor 5 (CCR5) delta 32 mutation
- Requiring the use of certain medications
- Lactating or pregnant women or subjects have reproductive potential unwilling to use an adequate method of birth control
- Chronic or recent serious or life-threatening infection; severe , progressive and/or uncontrollable renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease within 12 weeks of the first dose.
Trial locations and contacts
44 sites in 9 countries.
44 sites in 9 countries
United States21 sites
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Hamden, Connecticut, 06518
Pfizer Investigational Site
Hickory, North Carolina, 28601
Pfizer Investigational Site
Hickory, North Carolina, 28602
Pfizer Investigational Site
Huntington Beach, California, 92646
Pfizer Investigational Site
Kalamazoo, Michigan, 49007
Pfizer Investigational Site
Kalamazoo, Michigan, 49048
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Meriden, Connecticut, 06450
Pfizer Investigational Site
Minot, North Dakota, 58701
Pfizer Investigational Site
Moline, Illinois, 61265
Pfizer Investigational Site
New Haven, Connecticut, 06510-2716
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473
Pfizer Investigational Site
Omaha, Nebraska, 68154
Pfizer Investigational Site
Port Orange, Florida, 32127
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
Savannah, Georgia, 31405
Pfizer Investigational Site
Savannah, Georgia, 31406
Pfizer Investigational Site
Syracuse, New York, 13210
Spain4 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
Madrid, Madrid, 28007
Pfizer Investigational Site
Santiago de Compostela, A Coruña, 15705
Pfizer Investigational Site
Seville, Sevilla, 41014
Australia3 sites
Pfizer Investigational Site
Hobart, Tasmania, 7001
Pfizer Investigational Site
Maroochydore, Queensland, 4558
Pfizer Investigational Site
Woodville, South Australia, 5011
Germany3 sites
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Berlin, 14059
Pfizer Investigational Site
Leipzig, 04103
India3 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Bangalore, Karnataka, 560003
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 082
Portugal3 sites
Pfizer Investigational Site
Coimbra, 3000-075
Pfizer Investigational Site
Lisbon, 1000-247
Pfizer Investigational Site
Lisbon, 1600-035
Ukraine3 sites
Pfizer Investigational Site
Dnipropetrovsk, 49005
Pfizer Investigational Site
Kharkiv, 61000
Pfizer Investigational Site
Simferopol, 95017
Italy2 sites
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Pavia, 27100
Mexico2 sites
Pfizer Investigational Site
Guadalajara, Jalisco, 44690
Pfizer Investigational Site
Guadalajara, Jalisco, CP 44340
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Maraviroc in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients.
Read the detailed description
Following a planned interim analysis in the POC component on 21 August 2008 by the internal DMC (Data Monitoring Committee) of study A4001056, the trial was discontinued due to lack of efficacy. All participating investigators/country offices and monitors were notified on 22 August 2008 to cease patient enrollment. The DMC indicated that maraviroc was well tolerated in the Rheumatoid Arthritis patients and there were no safety concerns in the study. The termination date of this trial was 07 October 2008 when the last patient last visit occurred.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Maraviroc, Maraviroc Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.
Maraviroc PlaceboDrug
Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Not described Receives: Drug: Maraviroc Placebo |
| 1 | Experimental | This study was divided into two components: safety/pharmacokinetic (PK) and proof-of-concept (POC). In the safety/PK component either 150 mg or 300 mg tablets of maraviroc was administered twice a day (BID) to 16 rheumatoid arthritis subjects for 4 weeks. Receives: Drug: Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology (ACR) 20% Responders at Week 12
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).
Measured: Week 12
Secondary outcomes (24)
ACR 20% Responders at Weeks 1, 2, 4, and 8
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.
Measured: Weeks 1, 2, 4, and 8
ACR 50% Responders at Weeks 1, 2, 4, 8, and 12
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.
Measured: Weeks 1, 2, 4, 8, and 12
ACR 70% Responders at Weeks 1, 2, 4, 8, and 12
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.
Measured: Weeks 1, 2, 4, 8, and 12
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12
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.
Measured: Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12
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.
Measured: Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
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.
Measured: Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
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.
Measured: Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12
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.
Measured: Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12
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.
Measured: Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12
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.
Measured: Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12
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.
Measured: Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Mean Orthostatic Blood Pressure (BP)
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.
Measured: Baseline, 16 weeks
Change From Baseline in Mean Heart Rate
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.
Measured: Baseline, 16 weeks
Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline
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.
Measured: Baseline, 16 weeks
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]).
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.
Measured: Baseline, 16 weeks
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).
Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used.
Measured: Baseline, 16 weeks
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Maximum QTcB, QTcF, and QTc intervals were defined as 450 to < 480 msec, 480 to < 500 msec, or > = 500 msec.
Measured: Baseline, 16 weeks
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12
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.
Measured: Baseline, Weeks 4 and 12
Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12
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.
Measured: Baseline, Weeks 4 and 12
Number of Subjects With Withdrawal From Study Due to Lack of Efficacy
Withdrawal is the total number of withdrawals from the study. Withdrawal due to lack of efficacy was collected based on the investigator's judgement.
Measured: 16 weeks
Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.
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.
Measured: Weeks 1 to 12
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
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).
Measured: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1
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).
Measured: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1
PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).
Measured: Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: See Detailed Description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427934
- Sponsor's protocol ID
- A4001056
- Status last verified
- Oct 2014
- First submitted
- 25 Jan 2007
- Last updated
- 5 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fleishaker DL, Garcia Meijide JA, Petrov A, Kohen MD, Wang X, Menon S, Stock TC, Mebus CA, Goodrich JM, Mayer HB, Zeiher BG. Maraviroc, a chemokine receptor-5 antagonist, fails to demonstrate efficacy in the treatment of patients with rheumatoid arthritis in a randomized, double-blind placebo-controlled trial. Arthritis Res Ther. 2012 Jan 17;14(1):R11. doi: 10.1186/ar3685.
PubMed 22251436
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Maraviroc in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
- ClinicalTrials.gov ID
- NCT00427934
- Acronym / sponsor ID
- A4001056
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description.
- Enrolment
- 128 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Posted 5 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients.
Detailed description
Following a planned interim analysis in the POC component on 21 August 2008 by the internal DMC (Data Monitoring Committee) of study A4001056, the trial was discontinued due to lack of efficacy. All participating investigators/country offices and monitors were notified on 22 August 2008 to cease patient enrollment. The DMC indicated that maraviroc was well tolerated in the Rheumatoid Arthritis patients and there were no safety concerns in the study. The termination date of this trial was 07 October 2008 when the last patient last visit occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Maraviroc Placebo |
| 1 | Experimental | Drug: MaravirocThis study was divided into two components: safety/pharmacokinetic (PK) and proof-of-concept (POC). In the safety/PK component either 150 mg or 300 mg tablets of maraviroc was administered twice a day (BID) to 16 rheumatoid arthritis subjects for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be legal age of consent
- Must have active rheumatoid arthritis based upon the American College of Rheumatology (ACR) 1987 (Revised Criteria); minimum disease criteria required for entry into the efficacy component of the study
- Must meet ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III
- Must be receiving methotrexate for at least 12 weeks duration and on a stable dose for 4 weeks.
Key exclusion criteria (14 listed)
- Diagnosed with any other inflammatory arthritis or a secondary non-inflammatory arthritis that would interfere with disease activity assessments.
- Subject receiving prior treatment with certain medications for rheumatoid arthritis
- Tuberculosis and/or a positive tuberculin reaction
- Significant trauma or major surgery within 2 months
- History of alcohol and/or drug abuse outside of a defined period of abstinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maraviroc300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks. | Drug | 1 |
| Maraviroc PlaceboPlacebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks. | Drug | 2 |
Primary outcome
American College of Rheumatology (ACR) 20% Responders at Week 12
Time frame: Week 12
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).
24 secondary outcomes
ACR 20% Responders at Weeks 1, 2, 4, and 8
Time frame: Weeks 1, 2, 4, and 8
ACR 50% Responders at Weeks 1, 2, 4, 8, and 12
Time frame: Weeks 1, 2, 4, 8, and 12
ACR 70% Responders at Weeks 1, 2, 4, 8, and 12
Time frame: Weeks 1, 2, 4, 8, and 12
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
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
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
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
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
Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12
Time frame: Baseline, Weeks 1, 2, 4, 8, and 12
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
Change From Baseline in Mean Orthostatic Blood Pressure (BP)
Time frame: Baseline, 16 weeks
Change From Baseline in Mean Heart Rate
Time frame: Baseline, 16 weeks
Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline
Time frame: Baseline, 16 weeks
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
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).
Time frame: Baseline, 16 weeks
Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline
Time frame: Baseline, 16 weeks
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12
Time frame: Baseline, Weeks 4 and 12
Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12
Time frame: Baseline, Weeks 4 and 12
Number of Subjects With Withdrawal From Study Due to Lack of Efficacy
Time frame: 16 weeks
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
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22251436Fleishaker DL, Garcia Meijide JA, Petrov A, Kohen MD, Wang X, Menon S, Stock TC, Mebus CA, Goodrich JM, Mayer HB, Zeiher BG. Maraviroc, a chemokine receptor-5 antagonist, fails to demonstrate efficacy in the treatment of patients with rheumatoid arthritis in a randomized, double-blind placebo-controlled trial. Arthritis Res Ther. 2012 Jan 17;14(1):R11. doi: 10.1186/ar3685.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
44 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maraviroc in people with Arthritis, Rheumatoid, run by Pfizer at 44 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Spain, Australia, Germany, India and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology (ACR) 20% Responders at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.