PsoriasisPhase 4MOANCT00932113
Mechanism of Action Study for Psoriasis
A Phase 4 study testing Methotrexate and Adalimumab (Humira) in people with Psoriasis, run by Tufts Medical Center at 1 site in United States.
Trial summary
The objective of this study is to compare the mechanism of action between adalimumab and methotrexate in subjects with psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Methotrexate and Adalimumab (Humira)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to 1 May 2017
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-85 years of age with moderate to severe psoriasis, in general good health as determined by the PI based upon the results of medical history, laboratory profile, and physical examination, and who are candidates for systemic or phototherapy
- Presence of a psoriatic plaque of >2cm in an area which can be biopsied repeatedly.
- Men must agree to avoid impregnating a woman while on this study.
- Women are eligible to participate in the study if they meet one of the following criteria:
- Women who are postmenopausal (>1 year), sterile, or hysterectomized
- Women of childbearing potential must undergo monthly pregnancy testing during the study and agree to use two of the following methods of contraception throughout and for 60 days after the last dose of study drug:
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- Oral contraceptives
- Transdermal contraceptives
- Injectable or implantable methods
- Intrauterine devices
- Barrier methods (diaphragm or condom with spermicide)
- Abstinence and Tubal Ligation are also considered a form of Birth control
Who cannot join
- Patients <18 or >85 years old
- Absence of a psoriatic plaque >2cm in diameter
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
- Evidence of skin conditions at screening (e.g. eczema) that would interfere with evaluations of the effect of study medication
- Inability to understand the consent process
- Receipt of any investigational drugs, psoralen+ultraviolet A or oral systemic treatments within 4 weeks of study drug initiation
Show all 29Show fewer
- Biologics within 3 months of study initiation
- Topical steroids, topical vitamin A or D analog preparations, Ultraviolet B therapy or anthralin within 2 weeks of study drug initiation. (Exception-stable regimen of class I-II topical steroids on scalp, axillae, and groin)
- Methotrexate within 6 weeks of study initiation
- History of treatment with adalimumab
- History of primary non-response to methotrexate, infliximab or etanercept
- History of discontinuation of methotrexate or tumor necrosis factor (TNF) blocker for a safety-related reason that makes it unwise to restart either type of drug
- Any internal malignancy within 5 years (excluding fully excised cutaneous basal cell or squamous cell carcinoma)
- Pregnancy, not practicing effective birth control, or inability to practice safe sex during the length of the study
- Lactation
- Subjects who have known hypersensitivity to adalimumab or methotrexate or any of its components or who is known to have antibodies to etanercept
- History of alcohol or drug abuse one year before and during the study
- Known HIV-positive status or any other immune-suppressing disease
- Presence of a grade 3 or 4 infection <30 days prior to the screening visit, between the screening visit and the first day of treatment on study, or any time during the study that in the opinion of the PI would preclude participation in the study
- Any grade 3 or 4 adverse event, or laboratory toxicity, at the time of the screening visit or at any time during the study, which in the opinion of the PI would, preclude participation in the study
- Serum creatinine >3.0 mg/dL (265 micromoles/L)
- Serum potassium <3.5 mmol/L or > 5.5 mmol/L
- Serum alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal for the lab
- Platelet count <100,000/mm3
- White blood cell count <3,000/mm3
- Hgb, Hct, or red blood cell outside 30% of the upper or lower limits of normal for the Lab
- Receipt of live vaccines 1 month prior to or while on study
- History of tuberculosis, and/or a positive PPD skin test/chest x-ray at screening without appropriate treatment-treatment of latent tuberculosis (for those with positive PPD tests) must be initiated prior to therapy with adalimumab or methotrexate
- Chronic hepatitis B or C infection, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, 02111
About this study
Official title: An Investigator-Initiated, Assessor Blinded, Randomized Study Comparing the Mechanism of Action of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis.
The objective of this study is to compare the mechanism of action between adalimumab and methotrexate in subjects with psoriasis.
Read the detailed description
Both methotrexate and adalimumab are FDA-approved drugs for the treatment of moderate to severe psoriasis. The two treatments, methotrexate and adalimumab, both show efficacy for psoriasis, however their profiles differ. In the CHAMPION Study, more adalimumab-treated, moderate to severe psoriasis patients achieved a PASI 75 after 16 weeks compared to those treated with methotrexate (80% vs. 36%). The reason for this difference is poorly understood. No direct comparative mechanism of action studies in psoriasis patients between methotrexate and adalimumab (or any tumor necrosis factor blocker) has been reported.
With etanercept, another tumor necrosis factor blocker, the in vivo mechanism has been studied with some scientific rigor. These studies demonstrate that etanercept down regulates multiple pro-inflammatory pathways (as shown in Table 1 of the protocol).
To date, there are no similar studies with adalimumab or methotrexate.
In order to understand the molecular and cellular basis for the differential clinical efficacy of adalimumab and methotrexate, it is essential to compare their mechanisms of action in psoriatic plaques. Biopsies will be performed, and we will study biomarkers in this proposal with immunohistochemistry, real-time polymerase chain reaction, and gene arrays.
- Conditions
- Psoriasis
- Being tested
- Methotrexate, Adalimumab (Humira)
- Keywords
- tumor necrosis factor (TNF) inhibitor, tumor necrosis factor (TNF) blockade, Methotrexate, treatment, mechanism, psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Methotrexate (MTX), Folic Acid
2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.
Adalimumab (Humira)Drug
Also called Humira
2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Active comparator | Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15). Receives: Drug: Adalimumab (Humira) |
| Methotrexate (MTX) | Active comparator | Patients will be dosed according to the CHAMPION study in single weekly doses of methotrexate: 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study. Receives: Drug: Methotrexate; Drug: Adalimumab (Humira) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biologic Activity Endpoints
Histologic and Immunohistochemistry endpoints; Relative messenger RNA gene expression (normalized to HARP); and Gene Arrays.
Measured: Weeks 0, 1, 2, 4 and 16
Secondary outcomes (5)
Clinical Endpoints for Psoriasis: PASI 75
PASI 75 is the percent of subjects who experience an improvement in PASI (Psoriasis Area and Severity Index) score of at least 75% from their baseline PASI score.
Measured: Weeks 0 and week 16
Clinical Endpoints for Psoriasis: Physician's Global Assessment (PGA) Clear or Almost Clear (PGA 0-1)
Measured: Week 0 and Week 16
Clinical Endpoints for Psoriasis: % Body Surface Area
Measured: Week 0 and week 16
Clinical Endpoints for Psoriasis: Target Lesion Score
The lesion score of a single psoriatic plaque selected at baseline. Total range is 0 - 12 with 0 being clear and 12 representing the most severe disease. The target lesion score is composed of scale, erythema, and induration, each parameter is scored 0 (clear) through 4 (very severe). Totals are summed for target lesion score. S+E+I = TLS
Measured: Week 0 and Week 16
Clinical Endpoints for Psoriasis: Photography Completed
Measured: Week 0 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completion1 May 2017
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 (7)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice B. Gottlieb, M.D., PhD., Principal investigator, Tufts Medical Center, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932113
- Sponsor's protocol ID
- MOA
- Other IDs
- ABT 08-030
- Acronym
- MOA
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2009
- Last updated
- 31 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Malaviya R, Sun Y, Tan JK, Magliocco M, Gottlieb AB. Induction of lesional and circulating leukocyte apoptosis by infliximab in a patient with moderate to severe psoriasis. J Drugs Dermatol. 2006 Oct;5(9):890-3.
PubMed 17039656Malaviya R, Sun Y, Tan JK, Wang A, Magliocco M, Yao M, Krueger JG, Gottlieb AB. Etanercept induces apoptosis of dermal dendritic cells in psoriatic plaques of responding patients. J Am Acad Dermatol. 2006 Oct;55(4):590-7. doi: 10.1016/j.jaad.2006.05.004. Epub 2006 Jul 3.
PubMed 17010737Gottlieb AB, Chamian F, Masud S, Cardinale I, Abello MV, Lowes MA, Chen F, Magliocco M, Krueger JG. TNF inhibition rapidly down-regulates multiple proinflammatory pathways in psoriasis plaques. J Immunol. 2005 Aug 15;175(4):2721-9. doi: 10.4049/jimmunol.175.4.2721.
PubMed 16081850Tan JK, Aphale A, Malaviya R, Sun Y, Gottlieb AB. Mechanisms of action of etanercept in psoriasis. J Investig Dermatol Symp Proc. 2007 May;12(1):38-45. doi: 10.1038/sj.jidsymp.5650037.
PubMed 17502868Lizzul PF, Aphale A, Malaviya R, Sun Y, Masud S, Dombrovskiy V, Gottlieb AB. Differential expression of phosphorylated NF-kappaB/RelA in normal and psoriatic epidermis and downregulation of NF-kappaB in response to treatment with etanercept. J Invest Dermatol. 2005 Jun;124(6):1275-83. doi: 10.1111/j.0022-202X.2005.23735.x.
PubMed 15955104Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP, Unnebrink K, Kaul M, Camez A; CHAMPION Study Investigators. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008 Mar;158(3):558-66. doi: 10.1111/j.1365-2133.2007.08315.x. Epub 2007 Nov 28.
PubMed 18047523Goldminz AM, Suarez-Farinas M, Wang AC, Dumont N, Krueger JG, Gottlieb AB. CCL20 and IL22 Messenger RNA Expression After Adalimumab vs Methotrexate Treatment of Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):837-46. doi: 10.1001/jamadermatol.2015.0452.
PubMed 25946554
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated, Assessor Blinded, Randomized Study Comparing the Mechanism of Action of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT00932113
- Acronym / sponsor ID
- MOA / MOA
- Conditions
- Psoriasis
- Keywords
- tumor necrosis factor (TNF) inhibitor, tumor necrosis factor (TNF) blockade, Methotrexate, treatment, mechanism, psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the mechanism of action between adalimumab and methotrexate in subjects with psoriasis.
Detailed description
Both methotrexate and adalimumab are FDA-approved drugs for the treatment of moderate to severe psoriasis. The two treatments, methotrexate and adalimumab, both show efficacy for psoriasis, however their profiles differ. In the CHAMPION Study, more adalimumab-treated, moderate to severe psoriasis patients achieved a PASI 75 after 16 weeks compared to those treated with methotrexate (80% vs. 36%). The reason for this difference is poorly understood. No direct comparative mechanism of action studies in psoriasis patients between methotrexate and adalimumab (or any tumor necrosis factor blocker) has been reported.
With etanercept, another tumor necrosis factor blocker, the in vivo mechanism has been studied with some scientific rigor. These studies demonstrate that etanercept down regulates multiple pro-inflammatory pathways (as shown in Table 1 of the protocol).
To date, there are no similar studies with adalimumab or methotrexate.
In order to understand the molecular and cellular basis for the differential clinical efficacy of adalimumab and methotrexate, it is essential to compare their mechanisms of action in psoriatic plaques. Biopsies will be performed, and we will study biomarkers in this proposal with immunohistochemistry, real-time polymerase chain reaction, and gene arrays.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Active comparator | Drug: Adalimumab (Humira)Dosing will be on day 1 and then weekly. For the injections, dosing will occur according to product recommendations. Patients will receive 80mg adalimumab (2 pre-filled syringes, each with 40mg) on day 1, and then 40mg on week 1 and then every 2 weeks (from week 1 through week 15). |
| Methotrexate (MTX) | Active comparator | Drug: Methotrexate, Drug: Adalimumab (Humira)Patients will be dosed according to the CHAMPION study in single weekly doses of methotrexate: 7.5mg at week 0, 10mg at week two, and 15mg at week 4 for all patients. For each subject if the PASI did not decrease by at least 50% from baseline (PASI-50) at week 8, dosing will be increased to 20mg per week; the dose will be maintained at 15mg per week if PASI-50 was achieved at week 8. If PASI-50 was not achieved at week 12, dosing will be increased to 25mg per week; the dose will be maintained at 20mg per week if the PASI-50 was achieved at week 12. All patients on methotrexate will also receive a dietary supplement of oral folate (5mg per week). Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults 18-85 years of age with moderate to severe psoriasis, in general good health as determined by the PI based upon the results of medical history, laboratory profile, and physical examination, and who are candidates for systemic or phototherapy
- Presence of a psoriatic plaque of >2cm in an area which can be biopsied repeatedly.
- Men must agree to avoid impregnating a woman while on this study.
- Women are eligible to participate in the study if they meet one of the following criteria:
Key exclusion criteria (29 listed)
- Patients <18 or >85 years old
- Absence of a psoriatic plaque >2cm in diameter
- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
- Evidence of skin conditions at screening (e.g. eczema) that would interfere with evaluations of the effect of study medication
- Inability to understand the consent process
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 |
|---|---|---|
| MethotrexateAlso: Methotrexate (MTX), Folic Acid2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks. Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study. | Drug | Methotrexate (MTX) |
| Adalimumab (Humira)Also: Humira2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks. | Drug | Adalimumab, Methotrexate (MTX) |
Primary outcome
Biologic Activity Endpoints
Time frame: Weeks 0, 1, 2, 4 and 16
Histologic and Immunohistochemistry endpoints; Relative messenger RNA gene expression (normalized to HARP); and Gene Arrays.
5 secondary outcomes
Clinical Endpoints for Psoriasis: PASI 75
Time frame: Weeks 0 and week 16
Clinical Endpoints for Psoriasis: Physician's Global Assessment (PGA) Clear or Almost Clear (PGA 0-1)
Time frame: Week 0 and Week 16
Clinical Endpoints for Psoriasis: % Body Surface Area
Time frame: Week 0 and week 16
Clinical Endpoints for Psoriasis: Target Lesion Score
Time frame: Week 0 and Week 16
Clinical Endpoints for Psoriasis: Photography Completed
Time frame: Week 0 and Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17039656Malaviya R, Sun Y, Tan JK, Magliocco M, Gottlieb AB. Induction of lesional and circulating leukocyte apoptosis by infliximab in a patient with moderate to severe psoriasis. J Drugs Dermatol. 2006 Oct;5(9):890-3.
- Background: PubMed 17010737Malaviya R, Sun Y, Tan JK, Wang A, Magliocco M, Yao M, Krueger JG, Gottlieb AB. Etanercept induces apoptosis of dermal dendritic cells in psoriatic plaques of responding patients. J Am Acad Dermatol. 2006 Oct;55(4):590-7. doi: 10.1016/j.jaad.2006.05.004. Epub 2006 Jul 3.
- Background: PubMed 16081850Gottlieb AB, Chamian F, Masud S, Cardinale I, Abello MV, Lowes MA, Chen F, Magliocco M, Krueger JG. TNF inhibition rapidly down-regulates multiple proinflammatory pathways in psoriasis plaques. J Immunol. 2005 Aug 15;175(4):2721-9. doi: 10.4049/jimmunol.175.4.2721.
- Background: PubMed 17502868Tan JK, Aphale A, Malaviya R, Sun Y, Gottlieb AB. Mechanisms of action of etanercept in psoriasis. J Investig Dermatol Symp Proc. 2007 May;12(1):38-45. doi: 10.1038/sj.jidsymp.5650037.
- Background: PubMed 15955104Lizzul PF, Aphale A, Malaviya R, Sun Y, Masud S, Dombrovskiy V, Gottlieb AB. Differential expression of phosphorylated NF-kappaB/RelA in normal and psoriatic epidermis and downregulation of NF-kappaB in response to treatment with etanercept. J Invest Dermatol. 2005 Jun;124(6):1275-83. doi: 10.1111/j.0022-202X.2005.23735.x.
- Results publication: PubMed 18047523Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP, Unnebrink K, Kaul M, Camez A; CHAMPION Study Investigators. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008 Mar;158(3):558-66. doi: 10.1111/j.1365-2133.2007.08315.x. Epub 2007 Nov 28.
- Derived from this study: PubMed 25946554Goldminz AM, Suarez-Farinas M, Wang AC, Dumont N, Krueger JG, Gottlieb AB. CCL20 and IL22 Messenger RNA Expression After Adalimumab vs Methotrexate Treatment of Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):837-46. doi: 10.1001/jamadermatol.2015.0452.
- Individual participant dataSharing planned: No
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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.
Alice B. Gottlieb, M.D., PhD. principal investigator
Tufts Medical Center, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate and Adalimumab (Humira) in people with Psoriasis, run by Tufts Medical Center at 1 site in United States.
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 12 inclusion and 29 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 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2 Jul 2017). 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?
Biologic Activity Endpoints (time frame: Weeks 0, 1, 2, 4 and 16). 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 NCT00932113, which also lists 7 linked publications.
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 31 Aug 2017.