Rheumatoid ArthritisPhase 2MARS-1NCT00551707
Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis
A Phase 2 study testing CRx-102 (2.7/180), prednisolone and dipyridamole in people with Rheumatoid Arthritis, run by Zalicus at 48 sites in 12 countries.
Trial summary
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CRx-102 (2.7/180), prednisolone and dipyridamole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 48 sitesin 12 countries
- Study dates
- Oct 2007to Jan 2009
- 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
- Subject must voluntarily give written informed consent
- Subject must be ≥ 18 years of age
- Subject must have RA (ACR criteria)
- Subject must have at least 4 swollen joints and at least 6 tender joints at screening and baseline (28 joint count)
- Subject must have a CRP > Upper Limit of Normal at screening
- Subject must have been on DMARD or DMARD combination (e.g. MTX + hydroxychloroquine) for at least 3 months and be on a stable dose of DMARD(s) for at least 6 weeks prior to screening.
- For MTX subjects: MTX ≥ 7.5 mg weekly (po/sc/im) and willing to take folic acid or folinic acid supplementation
- Subject willing to take concomitant multivitamin or the equivalent of 400 I.U. vitamin D and the equivalent of 1000 mg of elemental calcium daily
Who cannot join
- History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
- Wheelchair or bed bound
- History of osteoporotic fracture
- History of malignancy within the past 10 years. However, subjects with a history of treated or excised basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate
- History of lymphoma or chronic leukemia
- Moles or lesions that are currently undiagnosed, but are suspicious for malignancy
Show all 34Show fewer
- Surgery within the previous 3 months (except for minor dental and cosmetic)
- History of drug or alcohol abuse (as defined by the Investigator)
- History of bleeding disorder
- History of gastrointestinal bleeding within 5 years of screening
- History of severe migraines or headaches
- History of glaucoma
- Active diabetic retinopathy
- Visually compromising cataract
- History of opportunistic infection within the previous 12 months
- Active Tuberculosis (TB)
- Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening
- Fever or symptomatic viral or bacterial infection within 2 weeks prior to screening
- Positive for Hepatitis C virus (HCV) antibody
- Positive for HBsAg
- Known positive HIV antibody
- Has a history of hypersensitivity to glucocorticoids and/or dipyridamole
- Treatment with oral, intra-articular, intramuscular, or intravenous glucocorticoids within 6 weeks prior to screening; inhaled glucocorticoid is permitted
- Treatment with any tumor necrosis factor-alpha (TNFα) biologic, anakinra or abatacept within 2 months prior to screening
- Treatment with rituximab
- Treatment with another investigational drug 3 months prior to screening
- Treatment with anticoagulants including: dipyridamole, warfarin, clopidogrel, ticlopidine; Acetylsalicylic acid > 150 mg per day
- Treatment with any concomitant medications that have not been at a stable dose for at least 28 days prior to screening
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) laboratory values that exceed 1.5 x ULN
- HbA1C value of > 7.0%
- Current enrollment in any other study with investigational drug or device
- Female subject who is pregnant or lactating or of child bearing potential and not using acceptable methods of contraception (birth control pills, barriers or abstinence)
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
- Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment
Trial locations and contacts
48 sites in 12 countries.
48 sites in 12 countries
United States13 sites
Study site
Anaheim, California
Study site
Birmingham, Alabama
Study site
Dallas, Texas
Study site
Elizabethtown, Kentucky
Study site
Haddon Heights, New Jersey
Study site
Huntsville, Alabama
Study site
La Jolla, California
Study site
Little Rock, Arkansas
Study site
Mayfield Village, Ohio
Study site
Oklahoma City, Oklahoma
Study site
Palm Harbor, Florida
Study site
Phoenix, Arizona
Study site
Westlake Village, California
Poland8 sites
Study site
Bialystok
Study site
Elblag
Study site
Katowice
Study site
Krakow
Study site
Lublin
Study site
Poznan
Study site
Torun
Study site
Warsaw
Argentina4 sites
Study site
Buenos Aires, Buenos Aires
Study site
Rosario, Santa Fe Province
Study site
San Jan
Study site
San Miguel de Tucumán
Canada4 sites
Study site
Hamilton, Ontario
Study site
St. John's, Newfoundland and Labrador
Study site
Windsor, Ontario
Study site
Winnipeg, Manitoba
South Africa3 sites
Study site
Cape Town, Western Cape
Study site
Pretoria, Gauteng
Study site
Worcester, Western Cape
Mexico2 sites
Study site
Aguascalientes, Aguascalientes
Study site
Vallarta Norte, Guadalajara
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA)
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis (RA).
In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted to reflect the current standard of care practices within rheumatology.
Read the detailed description
The study was discontinued before the enrollment objective was met. Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in C-reactive protein (CRP) values in the As-Treated population were calculated.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CRx-102 (2.7/180), prednisolone, dipyridamole, placebo, CRx-102 (2.7/360)
- Keywords
- CombinatoRx, CRx-102, Rheumatoid Arthritis, Prednisolone, Dipyridamole, ACR20
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRx-102 (2.7/180)Drug
Also called prednisolone 2.7 mg plus dipyridamole 180 mg
prednisolone 2.7 mg plus dipyridamole 180 mg
prednisoloneDrug
prednisolone (2.7 mg)
dipyridamoleDrug
Also called dipyridamole 360 mg
dipyridamole 360 mg
placeboDrug
placebo
CRx-102 (2.7/360)Drug
Also called Prednisolone 2.7 mg plus Dipyridamole 360 mg
Prednisolone 2.7 mg plus Dipyridamole 360 mg
| Study group | Role | What they receive |
|---|---|---|
| CRx-102 (2.7/180) | Experimental | CRx-102 dose 1 total daily dose during treatment period (days 14-98) 2.7 mg prednisolone plus 180 mg dipyridamole administered as 1.8 mg prednisolone plus 90 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 90 mg dipyridamole at 1 PM titration dose (days 0-13) 2.7 mg prednisolone plus 90 mg dipyridamole administered as 1.8 mg prednisolone plus 45 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 45 mg dipyridamole at 1 PM Receives: Drug: CRx-102 (2.7/180) |
| CRx-102 (2.7/360) | Experimental | CRx-102 Dose 2 total daily dose during treatment period (days 14-98) 2.7 mg prednisolone plus 360 mg dipyridamole administered as 1.8 mg prednisolone plus 180 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 180 mg dipyridamole at 1 PM titration dose 1 (days 0-6) 2.7 mg prednisolone plus 90 mg dipyridamole administered as 1.8 mg prednisolone plus 45 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 45 mg dipyridamole at 1 PM titration dose 2 (days 7-13) 2.7 mg prednisolone plus 180 mg dipyridamole administered as 1.8 mg prednisolone plus 90 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 90 mg dipyridamole at 1 PM Receives: Drug: CRx-102 (2.7/180); Drug: CRx-102 (2.7/360) |
| Prednisolone | Active comparator | treatment dose ( days 0-98) total daily dose of 2.7 mg prednisolone administered as 1.8 mg prednisolone at 8 AM and 0.9 mg prednisolone at 1 PM Receives: Drug: prednisolone |
| Dipyridamole | Active comparator | total daily dose during treatment period (days 14-98) 360 mg dipyridamole administered as 180 mg dipyridamole at 8 AM and and 180 mg dipyridamole at 1 PM titration dose 1 (days 0-6) 90 mg dipyridamole administered 45 mg dipyridamole at 8 AM and 45 mg dipyridamole at 1 PM titration dose 2 (days 7-13) 180 mg dipyridamole administered as 90 mg dipyridamole at 8 AM and 90 mg dipyridamole at 1 PM Receives: Drug: dipyridamole |
| Placebo | Placebo comparator | placebo administered twice per day at 8 AM and 1 PM Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population
Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Measured: Day 98
Secondary outcomes (3)
Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population
Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Measured: baseline to day 98
To Assess the Superiority of CRx-102 Compared to Prednisolone and Dipyridamole Using American College of Rheumatology Rating Scale (20% or More Improvement; ACR20) Calculated From Baseline to Day 98 in Subjects With Active Rheumatoid Arthritis
Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Measured: baseline to day 98
To Assess the Efficacy of CRx-102 Compared to Placebo Using ACR 20 Calculated From Baseline to Day 98
Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Measured: baseline to 98 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2008
- Study completionJan 2009
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.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zalicus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret Lee, PhD, Study director, Zalicus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551707
- Sponsor's protocol ID
- CRx-102-007
- Acronym
- MARS-1
- Status last verified
- Mar 2014
- First submitted
- 29 Oct 2007
- Last updated
- 29 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT00551707
- Acronym / sponsor ID
- MARS-1 / CRx-102-007
- Conditions
- Rheumatoid Arthritis
- Keywords
- CombinatoRx, CRx-102, Rheumatoid Arthritis, Prednisolone, Dipyridamole, ACR20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- ZalicusIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Posted 29 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis (RA).
In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted to reflect the current standard of care practices within rheumatology.
Detailed description
The study was discontinued before the enrollment objective was met. Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in C-reactive protein (CRP) values in the As-Treated population were calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CRx-102 (2.7/180) | Experimental | Drug: CRx-102 (2.7/180)CRx-102 dose 1 total daily dose during treatment period (days 14-98) 2.7 mg prednisolone plus 180 mg dipyridamole administered as 1.8 mg prednisolone plus 90 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 90 mg dipyridamole at 1 PM titration dose (days 0-13) 2.7 mg prednisolone plus 90 mg dipyridamole administered as 1.8 mg prednisolone plus 45 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 45 mg dipyridamole at 1 PM |
| CRx-102 (2.7/360) | Experimental | Drug: CRx-102 (2.7/180), Drug: CRx-102 (2.7/360)CRx-102 Dose 2 total daily dose during treatment period (days 14-98) 2.7 mg prednisolone plus 360 mg dipyridamole administered as 1.8 mg prednisolone plus 180 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 180 mg dipyridamole at 1 PM titration dose 1 (days 0-6) 2.7 mg prednisolone plus 90 mg dipyridamole administered as 1.8 mg prednisolone plus 45 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 45 mg dipyridamole at 1 PM titration dose 2 (days 7-13) 2.7 mg prednisolone plus 180 mg dipyridamole administered as 1.8 mg prednisolone plus 90 mg dipyridamole at 8 AM and 0.9 mg prednisolone plus 90 mg dipyridamole at 1 PM |
| Prednisolone | Active comparator | Drug: prednisolonetreatment dose ( days 0-98) total daily dose of 2.7 mg prednisolone administered as 1.8 mg prednisolone at 8 AM and 0.9 mg prednisolone at 1 PM |
| Dipyridamole | Active comparator | Drug: dipyridamoletotal daily dose during treatment period (days 14-98) 360 mg dipyridamole administered as 180 mg dipyridamole at 8 AM and and 180 mg dipyridamole at 1 PM titration dose 1 (days 0-6) 90 mg dipyridamole administered 45 mg dipyridamole at 8 AM and 45 mg dipyridamole at 1 PM titration dose 2 (days 7-13) 180 mg dipyridamole administered as 90 mg dipyridamole at 8 AM and 90 mg dipyridamole at 1 PM |
| Placebo | Placebo comparator | Drug: placeboplacebo administered twice per day at 8 AM and 1 PM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must voluntarily give written informed consent
- Subject must be ≥ 18 years of age
- Subject must have RA (ACR criteria)
- Subject must have at least 4 swollen joints and at least 6 tender joints at screening and baseline (28 joint count)
- Subject must have a CRP > Upper Limit of Normal at screening
Key exclusion criteria (34 listed)
- History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
- Wheelchair or bed bound
- History of osteoporotic fracture
- History of malignancy within the past 10 years. However, subjects with a history of treated or excised basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate
- History of lymphoma or chronic leukemia
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 |
|---|---|---|
| CRx-102 (2.7/180)Also: prednisolone 2.7 mg plus dipyridamole 180 mgprednisolone 2.7 mg plus dipyridamole 180 mg | Drug | CRx-102 (2.7/180), CRx-102 (2.7/360) |
| prednisoloneprednisolone (2.7 mg) | Drug | Prednisolone |
| dipyridamoleAlso: dipyridamole 360 mgdipyridamole 360 mg | Drug | Dipyridamole |
| placeboplacebo | Drug | Placebo |
| CRx-102 (2.7/360)Also: Prednisolone 2.7 mg plus Dipyridamole 360 mgPrednisolone 2.7 mg plus Dipyridamole 360 mg | Drug | CRx-102 (2.7/360) |
Primary outcome
Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population
Time frame: Day 98
Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
3 secondary outcomes
Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population
Time frame: baseline to day 98
To Assess the Superiority of CRx-102 Compared to Prednisolone and Dipyridamole Using American College of Rheumatology Rating Scale (20% or More Improvement; ACR20) Calculated From Baseline to Day 98 in Subjects With Active Rheumatoid Arthritis
Time frame: baseline to day 98
To Assess the Efficacy of CRx-102 Compared to Placebo Using ACR 20 Calculated From Baseline to Day 98
Time frame: baseline to 98 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rheumatoid Arthritis
Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
Active, not recruitingPhase 3
Nipocalimab in Moderate to Severe Sjogren's Disease
Sjogrens Syndrome
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
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.
Margaret Lee, PhD study director
Zalicus
48 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRx-102 (2.7/180), prednisolone and dipyridamole in people with Rheumatoid Arthritis, run by Zalicus at 48 sites in 12 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 8 inclusion and 34 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: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Poland, Argentina, Canada, Hungary and 7 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 29 Apr 2014). 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?
Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population (time frame: Day 98). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2014.