Rheumatoid ArthritisPhase 4NCT00796705
Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)
A Phase 4 study testing Adalimumab and Etanercept in people with Rheumatoid Arthritis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in United States.
Trial summary
Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. 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?
- Adalimumab and Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 16 sitesUnited States
- Study dates
- Nov 2008to Oct 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Rheumatoid Arthritis
- Current treatment with either etanercept or adalimumab for at least 12 weeks prior to randomization
- Disease Activity Score (DAS) C-reactive Protein (CRP) 28 ≥ 4.4
- Treatment with concomitant Disease-Modifying Anti-Rheumatic Drugs (DMARDs) is permitted but not required as described below:
- Methotrexate - maximum dose of 25 mg per os (PO), intra-muscular (IM), or SQ weekly.
- Leflunomide - maximum dose of 20 mg PO daily.
Show all 11Show fewer
- Sulfasalazine - maximum dose of 1,500 mg PO twice daily.
- Hydroxychloroquine - maximum dose of 400 mg PO daily.
- If taking DMARD(s), subjects must be on stable doses for at least 12 weeks prior to randomization.
- If treated with prednisone (or equivalent corticosteroid), on a stable dose of <= 10 mg/day for 28 days prior to randomization.
- Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.
Who cannot join
- Diagnosis of another autoimmune disease likely to require immunosuppression. More information on this criterion can be found in the protocol.
- Failing treatment with etanercept if previously treated with adalimumab
- Failing treatment with adalimumab if previously treated with etanercept
- Intraarticular injection within 4 weeks prior to randomization
- Concomitant use of DMARDs other than those described in Inclusion Criteria within 12 weeks of randomization.
- Concurrent use of any biologic agent other than etanercept or adalimumab
Show all 22Show fewer
- Concomitant immunosuppressive therapy other than the Disease-Modifying Anti-Rheumatic Drugs (DMARDs), non-steroidal anti-inflammatory drugs (NSAIDs), or corticosteroids specified in the protocol
- Presence of open leg ulcers
- Chronic or persistent infection that may be worsened by immunosuppressive treatment. More information on this criterion can be found in the protocol.
- Active infection or severe infections requiring hospitalization or treatment with intravenous antibiotics, antivirals, or antifungals within 30 days prior to randomization
- History of positive Purified Protein Derivative (PPD) or chest x-ray findings indicative of prior tuberculosis infection
- Any medical condition or treatment that, in the opinion of the investigator, would put the subject at risk by participation in the study
- History of malignancy. More information on this criterion can be found in the protocol.
- Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
- Investigational biological or chemical agents within 4 weeks prior to randomization.
- History of drug or alcohol abuse within a year prior to randomization
- Treatment with natalizumab, rituximab, or another B-cell depleting therapy within a year prior to randomization
- Treatment with infliximab, abatacept, tocilizumab, golimumab, or certolizumab pegol within 12 weeks prior to randomization.
- Known allergy or hypersensitivity to study products
- Any psychiatric disorder that prevents the participant from providing informed consent
- Inability to follow protocol instructions
- Pregnant or breastfeeding
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Alabama
Birmingham, Alabama, 35294
Carolina Bone and Joint
Charlotte, North Carolina, 28210
University of Chicago Medical Center
Chicago, Illinois, 60637
Baylor Research Institute
Dallas, Texas, 75231
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Duke University Medical Center
Durham, North Carolina, 27710
Justus Fiechtner, MD, PC
Lansing, Michigan, 48910
Feinstein Institute for Medical Research NS-LIJ
Manhassett, New York, 14642
Yale New Haven Hospital
New Haven, Connecticut, 06520
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Stanford University
Palo Alto, California, 94304
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
University of Rochester
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84132
Sarasota Arthritis Research Center
Sarasota, Florida, 34239
Tampa Medical Group
Tampa, Florida, 33614
About this study
Official title: Switching Anti-TNF-alpha Agents in Patients With RA With An Inadequate Response to TNF-alpha Inhibition
Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.
Read the detailed description
Over the past 10 years, advancements in biotechnology have revolutionized Rheumatoid Arthritis (RA) therapeutics with biologically-derived immunomodulating compounds. Tumor Necrosis Factor (TNF) alpha inhibitors constitute the largest class of these new biologic therapies. The purpose of this study is to determine the effectiveness of switching to an alternative TNF-alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA who have had inadequate clinical response to the study drugs etanercept and adalimumab.
This study will last approximately 16 weeks. Participants will be randomized into two arms and receive injections once per week for 12 weeks. Participants in the adalimumab arm will receive alternating subcutaneous adalimumab and adalimumab placebo injections. Participants in the etanercept arm will receive subcutaneous etanercept injections.
This study consists of thirteen study visits after randomization. Study visits will occur on a weekly basis for 12 weeks prior to a follow-up visit at Week 16. A vital signs measurement and adverse event assessment will occur at each visit. A physical exam, assessment of tender and swollen joints, medication assessment, and blood collection will occur at Weeks 4, 8, 12, and 16.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Adalimumab, Adalimumab placebo, Etanercept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
40 mg injection of adalimumab administered subcutaneously
Adalimumab placeboDrug
Also called Humira placebo
1.0 ml .9% saline placebo administered subcutaneously
EtanerceptDrug
Also called Enbrel
50 mg dimeric fusion protein administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab / Adalimumab Placebo | Experimental | 1 sub-cutaneous (SQ) injection of adalimumab or 1 SQ injection of placebo will be given in a blinded and alternating fashion for a total of 12 weeks Receives: Drug: Adalimumab; Drug: Adalimumab placebo |
| Etanercept | Experimental | Participants will receive 1 SQ injection of etanercept each week for 12 weeks Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).
Measured: Baseline, Week 12
Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).
Measured: Baseline, Week 12
Secondary outcomes (6)
Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).
Measured: Week 12
Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).
Measured: Week 12
Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response)
The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28[CRP] value of ≥ 1.2.
Measured: Baseline, Week 12
Participants With an ACR 20 Response at Week 12
The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:
- Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
- Patient's global assessment of disease activity (VAS 100 mm)
- Physician's global assessment of disease activity (VAS 100 mm)
- Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
- Acute phase reactant (CRP)
Measured: Week 12
Participants With an ACR 50 Response at Week 12
The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:
- Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
- Patient's global assessment of disease activity (VAS 100 mm)
- Physician's global assessment of disease activity (VAS 100 mm)
- Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
- Acute phase reactant (CRP)
Measured: Week 12
Participants With an ACR 70 Response at Week 12
The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:
- Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
- Patient's global assessment of disease activity (VAS 100 mm)
- Physician's global assessment of disease activity (VAS 100 mm)
- Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
- Acute phase reactant (CRP)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Lack of Enrollment
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 (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Larry Moreland, MD, Study chair, University of PittsburghMark Genovese, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796705
- Sponsor's protocol ID
- DAIT ARA05
- Status last verified
- Aug 2012
- First submitted
- 20 Nov 2008
- Last updated
- 4 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Villeneuve E, Haraoui B. To switch or to change class-the biologic dilemma in rheumatoid arthritis. Nat Rev Rheumatol. 2010 May;6(5):301-5. doi: 10.1038/nrrheum.2010.45. Epub 2010 Apr 13.
PubMed 20386564Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009;11 Suppl 1(Suppl 1):S1. doi: 10.1186/ar2666. Epub 2009 Apr 6.
PubMed 19368701van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998 Oct;41(10):1845-50. doi: 10.1002/1529-0131(199810)41:103.0.CO;2-K.
PubMed 9778226
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching Anti-TNF-alpha Agents in Patients With RA With An Inadequate Response to TNF-alpha Inhibition
- ClinicalTrials.gov ID
- NCT00796705
- Acronym / sponsor ID
- DAIT ARA05
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Enrollment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 13 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.
Detailed description
Over the past 10 years, advancements in biotechnology have revolutionized Rheumatoid Arthritis (RA) therapeutics with biologically-derived immunomodulating compounds. Tumor Necrosis Factor (TNF) alpha inhibitors constitute the largest class of these new biologic therapies. The purpose of this study is to determine the effectiveness of switching to an alternative TNF-alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA who have had inadequate clinical response to the study drugs etanercept and adalimumab.
This study will last approximately 16 weeks. Participants will be randomized into two arms and receive injections once per week for 12 weeks. Participants in the adalimumab arm will receive alternating subcutaneous adalimumab and adalimumab placebo injections. Participants in the etanercept arm will receive subcutaneous etanercept injections.
This study consists of thirteen study visits after randomization. Study visits will occur on a weekly basis for 12 weeks prior to a follow-up visit at Week 16. A vital signs measurement and adverse event assessment will occur at each visit. A physical exam, assessment of tender and swollen joints, medication assessment, and blood collection will occur at Weeks 4, 8, 12, and 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab / Adalimumab Placebo | Experimental | Drug: Adalimumab, Drug: Adalimumab placebo1 sub-cutaneous (SQ) injection of adalimumab or 1 SQ injection of placebo will be given in a blinded and alternating fashion for a total of 12 weeks |
| Etanercept | Experimental | Drug: EtanerceptParticipants will receive 1 SQ injection of etanercept each week for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of Rheumatoid Arthritis
- Current treatment with either etanercept or adalimumab for at least 12 weeks prior to randomization
- Disease Activity Score (DAS) C-reactive Protein (CRP) 28 ≥ 4.4
- Treatment with concomitant Disease-Modifying Anti-Rheumatic Drugs (DMARDs) is permitted but not required as described below:
- If taking DMARD(s), subjects must be on stable doses for at least 12 weeks prior to randomization.
Key exclusion criteria (22 listed)
- Diagnosis of another autoimmune disease likely to require immunosuppression. More information on this criterion can be found in the protocol.
- Failing treatment with etanercept if previously treated with adalimumab
- Failing treatment with adalimumab if previously treated with etanercept
- Intraarticular injection within 4 weeks prior to randomization
- Concomitant use of DMARDs other than those described in Inclusion Criteria within 12 weeks of randomization.
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 |
|---|---|---|
| AdalimumabAlso: Humira40 mg injection of adalimumab administered subcutaneously | Drug | Adalimumab / Adalimumab Placebo |
| Adalimumab placeboAlso: Humira placebo1.0 ml .9% saline placebo administered subcutaneously | Drug | Adalimumab / Adalimumab Placebo |
| EtanerceptAlso: Enbrel50 mg dimeric fusion protein administered subcutaneously | Drug | Etanercept |
Primary outcome
Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.
Time frame: Baseline, Week 12
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).
Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.
Time frame: Baseline, Week 12
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).
6 secondary outcomes
Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12
Time frame: Week 12
Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12
Time frame: Week 12
Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response)
Time frame: Baseline, Week 12
Participants With an ACR 20 Response at Week 12
Time frame: Week 12
Participants With an ACR 50 Response at Week 12
Time frame: Week 12
Participants With an ACR 70 Response at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20386564Villeneuve E, Haraoui B. To switch or to change class-the biologic dilemma in rheumatoid arthritis. Nat Rev Rheumatol. 2010 May;6(5):301-5. doi: 10.1038/nrrheum.2010.45. Epub 2010 Apr 13.
- Background: PubMed 19368701Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009;11 Suppl 1(Suppl 1):S1. doi: 10.1186/ar2666. Epub 2009 Apr 6.
- Background: PubMed 9778226van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998 Oct;41(10):1845-50. doi: 10.1002/1529-0131(199810)41:103.0.CO;2-K.
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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.
Larry Moreland, MD study chair
University of Pittsburgh
Mark Genovese, MD study chair
Stanford University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab and Etanercept in people with Rheumatoid Arthritis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites 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 11 inclusion and 22 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 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 13 Aug 2012). 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?
Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers. (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. 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 NCT00796705, which also lists 3 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 4 Oct 2012.