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AzTrials

Rheumatoid ArthritisPhase 3NCT00891020

A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)

A Phase 3 study testing tocilizumab [RoActemra/Actemra] and Nonbiologic DMARDs of investigator's choice in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 227 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. 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?
tocilizumab [RoActemra/Actemra] and Nonbiologic DMARDs of investigator's choice
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
886 participants
Where
227 sitesUnited States
Study dates
May 2009to Mar 2011
Phase
Phase 3
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

  • adult patients, >=18 years of age;
  • moderate to severe active rheumatoid arthritis for >6 months;
  • inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;
  • Swollen joint count (SJC) >/=4 and Tender joint count (TJC) >/=4
  • body weight </=150kg
  • current permitted non-biologic DMARDs must be on stable dose for >/= 7 weeks prior to baseline;

Who cannot join

  • history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
  • functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;
  • treatment with rituximab within 6 months before screening;
  • intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
  • known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.

Trial locations and contacts

227 sites in 1 country.

227 sites in 1 country

United States227 sites

  • Study site

    Akron, Ohio, 44333

  • Study site

    Albany, New York, 12206

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Amarillo, Texas, 79124

  • Study site

    Anniston, Alabama, 36207

  • Study site

    Arlington, Virginia, 22205

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Austin, Texas, 78705

  • Study site

    Austin, Texas, 78749

  • Study site

    Aventura, Florida, 33180

  • Study site

    Baton Rouge, Louisiana, 70808

  • Study site

    Baton Rouge, Louisiana, 70810

  • Study site

    Battle Creek, Michigan, 49015

  • Study site

    Beckley, West Virginia, 25801

  • Study site

    Belmont, North Carolina, 28012

  • Study site

    Bethlehem, Pennsylvania, 18015

  • Study site

    Binghamton, New York, 13905

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boise, Idaho, 83702

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Brookfield, Wisconsin, 53045

  • Study site

    Brooklyn, New York, 11201

  • Study site

    Burke, Virginia, 22015

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Carrollton, Texas, 75007

  • Study site

    Cedar Rapids, Iowa, 52401

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Chicago, Illinois, 60616

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45255

  • Study site

    Clarksburg, West Virginia, 26301

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Clifton, New Jersey, 07012

  • Study site

    Colorado Springs, Colorado, 80910

  • Study site

    Columbia, Maryland, 21045

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Columbus, Ohio, 43215

  • Study site

    Cooperstown, New York, 13326

  • Study site

    Covina, California, 91723

  • Study site

    Dallas, Texas, 75231-4406

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75246

  • Study site

    Danbury, Connecticut, 06810

  • Study site

    Dayton, Ohio, 45402

  • Study site

    Denver, Colorado, 80230

  • Study site

    Dover, New Hampshire, 03820

  • Study site

    Duluth, Minnesota, 55805

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Dunedin, Florida, 34698

  • Study site

    Durham, North Carolina, 27704

  • Study site

    Eagan, Minnesota, 55121

  • Study site

    Edina, Minnesota, 55435

  • Study site

    Ellicott City, Maryland, 21042

  • Study site

    Escondido, California, 92025

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fall River, Massachusetts, 02720

  • Study site

    Fayetteville, Arkansas, 27203

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Fort Smith, Arkansas, 72903

  • Study site

    Fort Wayne, Indiana, 46804

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Franklin, Wisconsin, 53132

  • Study site

    Frederick, Maryland, 21702

  • Study site

    Fullerton, California, 92835

  • Study site

    Gainesville, Florida, 30501

  • Study site

    Gainesville, Florida, 32608

  • Study site

    Gainesville, Georgia, 30501

  • Study site

    Gallipolis, Ohio, 45631

  • Study site

    Glendale, Wisconsin, 53217

  • Study site

    Grand Island, Nebraska, 68803

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Haddon Heights, New Jersey, 08035

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Hattiesburg, Mississippi, 39402

  • Study site

    Hendersonville, Tennessee, 37073

  • Study site

    Hewlett, New York, 11557

  • Study site

    Hickory Grove, South Carolina, 28602

  • Study site

    Hixson, Tennessee, 37343

  • Study site

    Hot Springs, Arizona, 71913

  • Study site

    Houston, Texas, 77074

  • Study site

    Houston, Texas, 77090

  • Study site

    Huntington Beach, California, 92646

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    Kalispell, Montana, 59901

  • Study site

    Knoxville, Tennessee, 37909

  • Study site

    La Jolla, California, 92037

  • Study site

    Lake Mary, Florida, 32746

  • Study site

    Lake Oswego, Oregon, 97035

  • Study site

    Lake Success, New York, 11042

  • Study site

    Lakewood, California, 90712

  • Study site

    Lansing, Michigan, 48910

  • Study site

    Las Cruces, New Mexico, 88011

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Lebanon, Pennsylvania, 17042

  • Study site

    Lees Summit, Kansas, 64086

  • Study site

    Lewes, Delaware, 19958

  • Study site

    Lexington, Kentucky, 40515

  • Study site

    Lincoln, Nebraska, 68516

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Long Beach, California, 90808

  • Study site

    Los Angeles, California, 90048

  • Study site

    Lubbock, Texas, 79424

  • Study site

    Manalapan, New Jersey, 07726

  • Study site

    Mayfield, Ohio, 44143

  • Study site

    Maywood, Illinois, 60153

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Mesquite, Texas, 75150

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami, Florida, 33133

  • Study site

    Middleburg Heights, Ohio, 44130

  • Study site

    Milwaukee, Wisconsin, 53209

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Moline, Illinois, 61265

  • Study site

    Monroe, Louisiana, 71203

  • Study site

    Montgomery, Alabama, 36111

  • Study site

    Morristown, New Jersey, 07962

  • Study site

    Morton Grove, Illinois, 60053

  • Study site

    Murrieta, California, 92563

  • Study site

    Myrtle Beach, South Carolina, 29572

  • Study site

    Nampa, Idaho, 83686

  • Study site

    Naples, Florida, 34102

  • Study site

    Nashville, Tennessee, 37027

  • Study site

    Nassau Bay, Texas, 77058

  • Study site

    New Brunswick, New Jersey, 08903

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10016

  • Study site

    Newport Beach, California, 92663

  • Study site

    Ocala, Florida, 34474

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oklahoma City, Oklahoma, 73109

  • Study site

    Olean, New York, 14760

  • Study site

    Olympia, Washington, 98502

  • Study site

    Onalaska, Wisconsin, 54605

  • Study site

    Orchard Park, New York, 14127

  • Study site

    Orlando, Florida, 32806

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Paradise Valley, Arizona, 85253

  • Study site

    Pasadena, California, 91107

  • Study site

    Pascagoula, Massachusetts, 39581

  • Study site

    Peabody, Massachusetts, 01960

  • Study site

    Peoria, Arizona, 85381

  • Study site

    Peoria, Illinois, 61602

  • Study site

    Perryburg, Ohio, 43551

  • Study site

    Petoskey, Michigan, 49770

  • Study site

    Philadelphia, Pennsylvania, 19141

  • Study site

    Philadelphia, Pennsylvania, 19152

  • Study site

    Plainview, New York, 11803

  • Study site

    Plymouth, Massachusetts, 02360

  • Study site

    Pottstown, Pennsylvania, 19464

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Reno, Nevada, 89502

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, New York, 14618

  • Study site

    Rock Hill, North Carolina, 29732

  • Study site

    Roslyn, New York, 11576

  • Study site

    Sacramento, California, 95825

  • Study site

    Saint Clair Shores, Michigan, 48080

  • Study site

    Saint Louis Park, Minnesota, 55426

  • Study site

    San Antonio, Texas, 78217

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78258

  • Study site

    San Diego, California, 92108

  • Study site

    San Leandro, California, 94578

  • Study site

    Santa Barbara, California, 93108

  • Study site

    Santa Maria, California, 93454

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Schaumburg, Illinois, 60195

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Sherman Oaks, California, 91423

  • Study site

    Smithtown, New York, 11787

  • Study site

    South Bend, Indiana, 46601

  • Study site

    South Miami, Florida, 33143

  • Study site

    Spokane, Washington, 99204

  • Study site

    Springfield, Illinois, 62704

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St Louis, Missouri, 63141

  • Study site

    St. Petersburg, Florida, 33710

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33614

  • Study site

    Tampa, Florida, 33618

  • Study site

    Trenton, New Jersey, 08360

  • Study site

    Trumbull, Connecticut, 06611

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tulsa, Oklahoma, 74135

  • Study site

    Tupelo, Mississippi, 38802

  • Study site

    Tuscaloosa, Alabama, 35406

  • Study site

    Tyler, Texas, 75701

  • Study site

    Utica, New York, 13504

  • Study site

    Van Nuys, California, 91405

  • Study site

    Vernon Hills, Illinois, 60061

  • Study site

    Victorville, California, 92295

  • Study site

    Virginia Beach, Virginia, 23454

  • Study site

    Voorhees Township, New Jersey, 08043

  • Study site

    Waco, Texas, 76708

  • Study site

    West Reading, Pennsylvania, 19611

  • Study site

    Westlake Village, California, 91361

  • Study site

    Wexford, Pennsylvania, 15090

  • Study site

    Wheaton, Maryland, 20902

  • Study site

    Whittier, California, 90606

  • Study site

    Wichita, Kansas, 67208

  • Study site

    Willow Grove, Pennsylvania, 19090

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Worcester, Massachusetts, 01605

  • Study site

    Worcester, Massachusetts, 01610

  • Study site

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs

This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership with the FDA to manage known and potential risks associated with the treatment of tocilizumab. Patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.

Being tested
tocilizumab [RoActemra/Actemra], Nonbiologic DMARDs of investigator's choice
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tocilizumab [RoActemra/Actemra]Drug

    8 mg/kg intravenous every 4 weeks for 24 weeks

  • tocilizumab [RoActemra/Actemra]Drug

    4 mg/kg every 4 weeks for 24 weeks

  • Nonbiologic DMARDs of investigator's choiceDrug

    Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed

Study groups in NCT00891020
Study groupRoleWhat they receive
Tocilizumab 8 mg/kg MonotherapyExperimentalParticipants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Receives: Drug: tocilizumab [RoActemra/Actemra]
Tocilizumab 4 mg/kg + DMARDExperimentalParticipants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Receives: Drug: tocilizumab [RoActemra/Actemra]; Drug: Nonbiologic DMARDs of investigator's choice
Tocilizumab 8 mg/kg + DMARDExperimentalParticipants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Receives: Drug: tocilizumab [RoActemra/Actemra]; Drug: Nonbiologic DMARDs of investigator's choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period

    An SAE was any adverse event that at any dose fulfilled at least one of the following criteria:

    • Was fatal (results in death)
    • Was life-threatening
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was medically significant or required intervention to prevent one or other of the outcomes listed above.

    Measured: 24 Weeks

Secondary outcomes (9)

  1. Percentage of Participants Experiencing Serious Adverse Events of Special Interest

    Serious Adverse Events of Special interest include:

    • Serious infections including opportunistic infections
    • Complications of diverticulitis (including lower gastrointestinal [GI] perforations)
    • Myocardial infarction/acute coronary syndrome
    • Stroke
    • Spontaneous or serious bleeding
    • Malignant neoplasms

    Measured: 24 Weeks

  2. Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest

    Non-serious adverse Events of Special interest include:

    • Serious/Medically Significant Hepatic Events
    • Spontaneous /Serious Bleeding
    • Malignant Neoplasms

    Measured: 24 Weeks

  3. Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24

    Clinical Remission is defined as a Disease Activity Score 28 [DAS28] < 2.6. The DAS28 is a combined index for measuring disease activity in RA. The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

    Measured: Weeks 8,16,24

  4. Change From Baseline in DAS28 Score at Weeks 8, 16 and 24

    The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response C-reactive protein (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of ≤ 3.2 represents low disease activity, and a score of > 5.1 represents high disease activity.

    The Change from Baseline to Weeks 8, 16 and 24 is reported.

    Measured: Baseline, Weeks 8,16,24

  5. Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24

    The ACR response rates ACR20, ACR50, and ACR70 are defined as ≥20%, ≥50%, and ≥70% improvement from baseline, respectively, in:

    1. Swollen Joint Count (66 joints) and Tender Joint Count (68 joints) and
    2. At least 3 of the following 5 assessments:
    • Patient's global assessment of pain-Visual Analog Scale (VAS)
    • Patient global assessment of disease activity-(VAS)
    • Physician global assessment of disease activity-(VAS)
    • Patient assessment of disability (physical function scale of the Multidimensional Health Assessment Questionnaire)
    • Acute phase response C-Reactive Protein (CRP)

    Measured: Baseline, Weeks 8,16,24

  6. Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8

    Dosage could be increased from 4 mg/kg Tocilizumab to 8 mg/kg due to failure to achieve 20% improvement from baseline in swollen and tender joint counts.

    Measured: Baseline, Week 8

  7. Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20

    Dosage of Tocilizumab 4 mg/kg could be increased to 8 mg/kg at the discretion of the investigator based on assessment of the patient's benefit-risk after Week 12.

    Measured: Weeks 12,16, 20

  8. Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24

    The RAPID3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain Visual Analog Scale (VAS), and global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 10 where higher scores represent worse outcomes. A negative change from baseline indicates improvement.

    Measured: Baseline, Weeks 8,16,24

  9. Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24

    The fatigue VAS is a single-item, patient-reported outcome that measures the severity of the fatigue over the past week. Patients rate their fatigue on a scale of 0 (fatigue is no problem) to 100 (fatigue is a major problem). Higher scores represent higher disease activity and a negative change from baseline indicates improvement.

    Measured: Baseline, Weeks 8,16,24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionJul 2010
  4. Study completionMar 2011

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
886 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00891020
Sponsor's protocol ID
ML22533
Status last verified
Oct 2012
First submitted
29 Apr 2009
Last updated
25 Oct 2012

Publications

  • Weinblatt ME, Kremer J, Cush J, Rigby W, Teng LL, Devenport J, Singh N, Lepley D, Genovese MC. Tocilizumab as monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs: twenty-four-week results of an open-label, clinical practice study. Arthritis Care Res (Hoboken). 2013 Mar;65(3):362-71. doi: 10.1002/acr.21847.

    PubMed 22972745

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tocilizumab [RoActemra/Actemra] and Nonbiologic DMARDs of investigator's choice in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 227 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 6 inclusion and 5 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 25 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 227 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Apr 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?

Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period (time frame: 24 Weeks). 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 NCT00891020, 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 25 Oct 2012.

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