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Ulcerative ColitisPhase 3NCT01532648

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

A Phase 3 study testing Budesonide MMX® and 5-ASA in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 114 sites in 11 countries.

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 study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Budesonide MMX® and 5-ASA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
510 participants
Where
114 sitesin 11 countries
Study dates
27 Jan 2012to 2 Oct 2013
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75 years, inclusive.
  • Established diagnosis of UC, based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
  • Active mild or moderate UC with an ulcerative colitis disease activity index (UCDAI) score ≥4 and ≤10, with a mucosal appearance score of ≥1, and physician's rating of disease activity of 1 or 2.
  • Experiencing active UC (flare) despite a therapeutic dose of an oral 5-ASA (for example, mesalamine ≥2.4 g/day for ≥6 weeks prior to randomization, or equivalent). At screening, photographic evidence of active UC based on mucosal appearance must be obtained.
  • Women of childbearing potential or men of reproductive potential must be willing to use an acceptable form of contraception.
  • Able to comprehend the full nature and purpose of the study, including possible risks and side effects, and also able to comply with all requirements of the study. Must be able to understand and voluntarily sign an informed consent prior to any study procedures.

Who cannot join

  • Limited distal proctitis (from anal verge to 15 centimeters [cm] above the pectineal line).
  • Severe UC (UCDAI >10 or physician global assessment [PGA] >2), or non-active UC (UCDAI <4).
  • Infectious colitis or any recent history of infectious colitis (within 30 days of Screening).
  • Active malignancy or carcinoma in situ within the last 5 years (treated non-melanoma skin cancers are not exclusionary).
  • Active ulcer or bleeding disorder that may affect evaluation of blood in the stool.
  • Evidence or history of toxic megacolon or bowel resection.
Show all 24Show fewer
  • Crohn's disease or indeterminate colitis.
  • Known hypersensitivity to budesonide or any ingredients of the budesonide MMX tablets.
  • Active tuberculosis or other active systemic or local bacterial, fungal, or viral infection.
  • Liver cirrhosis, evident hepatic or renal disease or insufficiency, or significant impairment of the biohumoral parameters (≥2.5*upper limit of normal [ULN] for alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or ≥2*ULN for creatinine). Elevations in bilirubin due to benign conditions such as Gilbert's syndrome are not exclusionary.
  • Severe diseases in other organs or systems.
  • Local or systemic complications or other pathological states requiring therapy with corticosteroids and/or immunosuppressive agents.
  • Type 1 diabetes.
  • Glaucoma or with a family history of glaucoma in first-degree relatives.
  • Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), according to the local privacy policy.
  • Severe anemia (<9 g/deciliter [dL] hemoglobin), leukopenia (<2.5*10^9 white blood cells [WBC]/liter [L]), or granulocytopenia (<1.2*10^9 cells/L).
  • Participants with a history of pancolitis (disease that extends to the hepatic flexure or beyond) for ≥8 years or left-sided colitis (disease confined to the left colon [that is, distal to the splenic flexure]) ≥15 years who have not yet completed a surveillance colonoscopy for dysplasia/colorectal cancer screening within the past year.
  • Prior budesonide MMX treatment.
  • Use of oral corticosteroids including other budesonide formulations within the last 4 weeks prior to randomization.
  • Use of any rectal 5-ASA or corticosteroid formulations within the last 2 weeks prior to randomization.
  • Use of immunosuppressive agents within the last 8 weeks prior to randomization.
  • Use of anti-tumor necrosis factor-alpha (TNFα) agents or other biologic therapies within the last 3 months prior to randomization.
  • Participation in experimental therapeutic studies within 30 days of randomization (or within the last 3 months if in an anti-TNFα or biologic agent study). Note: participants who participated in observational-only studies (and who did not receive study therapy) are not excluded.
  • Any other medical condition that, in the Principal Investigator's opinion, would make the administration of the study drug or study procedures hazardous to the participant or obscure the interpretation of adverse events (AEs) by the appropriate independent ethics committee/institutional review board.

Trial locations and contacts

114 sites in 11 countries.

114 sites in 11 countries

United States39 sites

  • Santarus Clinical Investigational Site 1043

    Anaheim, California, 92801

  • Santarus Clinical Investigational Site 1044

    Annapolis, Maryland, 21401

  • Santarus Clinical Investigational Site 1059

    Austin, Texas, 78705

  • Santarus Clinical Investigational Site 1035

    Boynton Beach, Florida, 33426

  • Santarus Clinical Investigational Site 1028

    Bristol, Connecticut, 06010

  • Santarus Clinical Investigational Site 1021

    Cheektowaga, New York, 14225

  • Santarus Clinical Investigational Site 1038

    Chesapeake, Virginia, 23320

  • Santarus Clinical Investigational Site 1016

    Chesterfield, Michigan, 48047

  • Santarus Clinical Investigational Site 1075

    Chicago, Illinois, 60637

  • Santarus Clinical Investigational Site 1025

    Christiansburg, Virginia, 24073

  • Santarus Clinical Investigational Site 1080

    Cincinnati, Ohio, 45267

  • Santarus Clinical Investigational Site 1078

    Cleveland, Ohio, 44195

  • Santarus Clinical Investigational Site 1082

    Dayton, Ohio, 45415

  • Santarus Clinical Investigational Site 1050

    Decatur, Georgia, 30033

  • Santarus Clinical Investigational Site 1072

    Great Neck, New York, 11023

  • Santarus Clinical Investigational Site 1039

    Houston, Texas, 77030

  • Santarus Clinical Investigational Site 1058

    Indianapolis, Indiana, 46202

  • Santarus Clinical Investigational Site 1045

    Jacksonville, Florida, 32256

  • Santarus Clinical Investigational Site 1071

    Lakewood, California, 90712

  • Santarus Clinical Investigational Site 1064

    Lancaster, Pennsylvania, 17604

  • Santarus Clinical Investigational Site 1014

    Lancaster, Utah, 84341

  • Santarus Clinical Investigational Site 1001

    Largo, Florida, 33777

  • Santarus Clinical Investigational Site 1061

    Lebanon, New Hampshire, 03756

  • Santarus Clinical Investigational Site 1063

    Littleton, Colorado, 80120

  • Santarus Clinical Investigational Site 1024

    Maitland, Florida, 32751

  • Santarus Clinical Investigational Site 1031

    New York, New York, 10028

  • Santarus Clinical Investigational Site 1081

    Novi, Michigan, 48377

  • Santarus Clinical Investigational Site 1065

    Oak Lawn, Illinois, 60453

  • Santarus Clinical Investigational Site 1005

    Pasadena, Texas, 77505

  • Santarus Clinical Investigational Site 1029

    Port Orange, Florida, 32127

  • Santarus Clinical Investigational Site 1074

    Rochester, Minnesota, 55905

  • Santarus Clinical Investigational Site 1003

    San Diego, California, 92114

  • Santarus Clinical Investigational Site 1006

    Sayre, Pennsylvania, 18840

  • Santarus Clinical Investigational Site 1032

    Shreveport, Louisiana, 71103

  • Santarus Clinical Investigational Site 1073

    Wilmington, North Carolina, 28403

  • Santarus Clinical Investigational Site 1010

    Winter Park, Florida, 32789

  • Santarus Clinical Investigational Site 1015

    Wyoming, Michigan, 49159

  • Santarus Clinical Investigational Site 1068

    Ypsilanti, Michigan, 48197

  • Santarus Clinical Investigational Site 1002

    Zephyrhills, Florida, 33613

Other trials in United States

Russia13 sites

  • Santarus Clinical Investigational Site 9016

    Lipetsk

  • Santarus Clinical Investigational Site 9005

    Moscow

  • Santarus Clinical Investigational Site 9010

    Moscow

  • Santarus Clinical Investigational Site 9004

    Nizhny Novgorod

  • Santarus Clinical Investigational Site 9003

    Ryazan

  • Santarus Clinical Investigational Site 9001

    Saint Petersburg

  • Santarus Clinical Investigational Site 9008

    Saint Petersburg

  • Santarus Clinical Investigational Site 9013

    Saint Petersburg

  • Santarus Clinical Investigational Site 9014

    Saint Petersburg

  • Santarus Clinical Investigational Site 9009

    Saratov

  • Santarus Clinical Investigational Site 9007

    Stavropol

  • Santarus Clinical Investigational Site 9006

    Ufa

  • Santarus Clinical Investigational Site 9017

    Volgograd

Other trials in Russia

Hungary11 sites

  • Santarus Clinical Investigational Site 5010

    Békéscsaba

  • Santarus Clinical Investigational Site 5008

    Budapest

  • Santarus Clinical Investigational Site 5009

    Budapest

  • Santarus Clinical Investigational Site 5001

    Debrecen

  • Santarus Clinical Investigational Site 5003

    Gyula

  • Santarus Clinical Investigational Site 5004

    Kaposvár

  • Santarus Clinical Investigational Site 5002

    Miskolc

  • Santarus Clinical Investigational Site 5006

    Mosonmagyaróvár

  • Santarus Clinical Investigational Site 5011

    Pécs

  • Santarus Clinical Investigational Site 5005

    Szeged

  • Santarus Clinical Investigational Site 5007

    Vác

Other trials in Hungary

Bulgaria10 sites

  • Santarus Clinical Investigational Site 4003

    Pleven

  • Santarus Clinical Investigational Site 4004

    Plovdiv

  • Santarus Clinical Investigational Site 4009

    Plovdiv

  • Santarus Clinical Investigational Site 4008

    Rousse

  • Santarus Clinical Investigational Site 4001

    Sofia

  • Santarus Clinical Investigational Site 4002

    Sofia

  • Santarus Clinical Investigational Site 4005

    Sofia

  • Santarus Clinical Investigational Site 4007

    Sofia

  • Santarus Clinical Investigational Site 4010

    Sofia

  • Santarus Clinical Investigational Site 4011

    Sofia

Other trials in Bulgaria

Canada10 sites

  • Santarus Clinical Investigational Site 2007

    Calgary

  • Santarus Clinical Investigational Site 2008

    Halifax, Nova Scotia

  • Santarus Clinical Investigational Site 2004

    London, Ontario

  • Santarus Clinical Investigational Site 2005

    London

  • Santarus Clinical Investigational Site 2009

    Montreal, Quebec

  • Santarus Clinical Investigational Site 2010

    Ottawa, Ontario

  • Santarus Clinical Investigational Site 2006

    Québec

  • Santarus Clinical Investigational Site 2001

    Sherbrooke, Quebec, J1G2E8

  • Santarus Clinical Investigational Site 2002

    Vaughan, Ontario, L4L4Y7

  • Santarus Clinical Investigational Site 2003

    Winnipeg, Manitoba, R3A1R9

Other trials in Canada

Czechia10 sites

  • Santarus Clinical Investigational Site 3001

    Hradec Králové

  • Santarus Clinical Investigational Site 3006

    Hradec Králové

  • Santarus Clinical Investigational Site 3005

    Labem

  • Santarus Clinical Investigational Site 3003

    Olomouc

  • Santarus Clinical Investigational Site 3004

    Prague

  • Santarus Clinical Investigational Site 3007

    Prague

  • Santarus Clinical Investigational Site 3009

    Prague

  • Santarus Clinical Investigational Site 3002

    Tábor

  • Santarus Clinical Investigational Site 3010

    Ústí nad Orlicí

  • Santarus Clinical Investigational Site 3011

    Valašské Meziříčí

Other trials in Czechia

Poland7 sites

  • Santarus Clinical Investigational Site 6003

    Elblag

  • Santarus Clinical Investigational Site 6001

    Krakow

  • Santarus Clinical Investigational Site 6002

    Sopot

  • Santarus Clinical Investigational Site 6006

    Szczecin

  • Santarus Clinical Investigational Site 6004

    Warsaw

  • Santarus Clinical Investigational Site 6008

    Warsaw

  • Santarus Clinical Investigational Site 6005

    Warszawy

Other trials in Poland

Ukraine7 sites

  • Santarus Clinical Investigational Site 7010

    Crimea

  • Santarus Clinical Investigational Site 7002

    Donetsk

  • Santarus Clinical Investigational Site 7001

    Kharkiv

  • Santarus Clinical Investigational Site 7004

    Kharkiv

  • Santarus Clinical Investigational Site 7006

    Kyiv

  • Santarus Clinical Investigational Site 7008

    Kyiv

  • Santarus Clinical Investigational Site 7005

    Vinnytsia

Other trials in Ukraine

Latvia3 sites

  • Santarus Clinical Investigational Site 8101

    Riga

  • Santarus Clinical Investigational Site 8102

    Riga

  • Santarus Clinical Investigational Site 8103

    Riga

Other trials in Latvia

Lithuania3 sites

  • Santarus Clinical Investigational Site 8202

    Kaunas

  • Santarus Clinical Investigational Site 8201

    Vilnius

  • Santarus Clinical Investigational Site 8203

    Vilnius

Other trials in Lithuania

Estonia1 site

  • Santarus Clinical Investigational Site 8001

    Tallinn

Other trials in Estonia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen

This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

Read the detailed description

Eligible participants will be randomized to 1 of the following 2 treatment arms:

  1. Budesonide MMX 9 mg (1 tablet)
  2. Placebo (tablet indistinguishable from budesonide MMX 9 mg tablet)

The assigned study drug will be taken as a single oral tablet each morning after breakfast. In addition to the study drug, all participants will continue their existing background oral 5-ASA regimen during the treatment period.

Being tested
Budesonide MMX®, Placebo, 5-ASA
Keywords
Ulcerative Colitis
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • Budesonide MMX®Drug

    Also called Budesonide Multi-Matrix System

    Oral tablet taken daily in the morning after breakfast.

  • PlaceboDrug

    Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast.

  • 5-ASADrug

    Acceptable oral 5-ASA medications to be received during the study include:

    • Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)
    • Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g
    • Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g
    • Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g
Study groups in NCT01532648
Study groupRoleWhat they receive
Budesonide MMXExperimentalParticipants will receive 1 oral tablet of budesonide MMX 9 mg for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician.
Receives: Drug: Budesonide MMX®; Drug: 5-ASA
PlaceboPlacebo comparatorParticipants will receive 1 oral tablet of matching budesonide MMX placebo for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician.
Receives: Drug: Placebo; Drug: 5-ASA

What is being measured

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

  1. Number of Participants Who Achieved Clinical Remission at Day 56

    Clinical remission defined as a score of 0 for rectal bleeding and 0 for stool frequency components from the Ulcerative Colitis Disease Activity Index (UCDAI). UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If either subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis. Participants who had clinical remission at Baseline were classified as non-responders.

    Measured: Baseline up to Day 56

Secondary outcomes (6)

  1. Number of Participants of Who Achieved Clinical Response at Day 56

    Clinical response defined as an improvement in UCDAI from Baseline of ≥3 points with a rectal bleeding score ≤1. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Rectal bleeding was based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If either subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.

    Measured: Baseline up to Day 56

  2. Number of Participants Who Achieved UCDAI Remission at Day 56

    UCDAI remission was defined as a total UCDAI score ≤1 with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance of the colon. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries and mucosal appearance was based on endoscopy results. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If the subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.

    Measured: Baseline up to Day 56

  3. Number of Participants Who Achieved Endoscopic Remission at Day 56

    Endoscopic remission was defined as a score of 0 in the mucosal appearance component subscore of the UCDAI at Day 56. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Mucosal appearance was based on endoscopy results. If the mucosal appearance subscore could not be calculated because of missing data, endoscopic remission was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.

    Measured: Screening and Day 56

  4. Number of Participants Who Achieved Histologic Healing at Day 56

    Participants achieved histologic healing if histologic assessments of all biopsy specimens were graded as 0 (normal mucosa). If the score for ≥1 sample was missing, the overall score at that visit was set to missing. Participants with insufficient data at Day 56 were excluded from analysis.

    Measured: Baseline and Day 56

  5. Number of Participants With Treatment Failure at Day 56

    Treatment failure was defined as an unchanged, worsened, or missing UCDAI score at Day 56. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding was based on information recorded in daily participant diaries and mucosal appearance was based on endoscopy results. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If the subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.

    Measured: Baseline up to Day 56

  6. Change From Baseline in Inflammatory Bowel Disease-Quality of Life (IBD-QoL) Questionnaire Scores

    The IBD-QoL questionnaire was self-completed by the participant. The IBD-QoL is a disease-specific instrument to evaluate the quality of life of participants with UC. This 32-item questionnaire has 4 dimensions: bowel function, emotional function, systemic symptoms, and social function. The total score is presented, which ranges from 32 to 224, with higher scores indicating a better quality of life. The scores of participants in remission usually range from 170 to 190. If >50% of the questionnaire answers for a particular dimension were missing, this dimension score was set to missing. The total score for the IBD-QoL was the sum of the domain scores, however, if any dimension score was missing, the total IBD-QoL score was set to missing.

    Measured: Baseline, Days 14, 28, and 56

Timeline

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

  1. First posted14 Feb 2012 (estimated)
  2. Study start27 Jan 2012
  3. Primary completion2 Oct 2013
  4. Study completion2 Oct 2013

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01532648
Sponsor's protocol ID
C2011-0401
Status last verified
Aug 2019
First submitted
13 Dec 2011
Last updated
6 Sep 2019
Data monitoring committee
No

Publications

  • Rubin DT, Cohen RD, Sandborn WJ, Lichtenstein GR, Axler J, Riddell RH, Zhu C, Barrett AC, Bortey E, Forbes WP. Budesonide Multimatrix Is Efficacious for Mesalamine-refractory, Mild to Moderate Ulcerative Colitis: A Randomised, Placebo-controlled Trial. J Crohns Colitis. 2017 Jul 1;11(7):785-791. doi: 10.1093/ecco-jcc/jjx032.

    PubMed 28333362

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide MMX® and 5-ASA in people with Ulcerative Colitis, run by Bausch Health Americas, Inc. at 114 sites in 11 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 6 inclusion and 24 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Russia, Hungary, Bulgaria, Canada and 6 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 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 6 Sep 2019). 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?

Number of Participants Who Achieved Clinical Remission at Day 56 (time frame: Baseline up to Day 56). 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 NCT01532648, 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 6 Sep 2019.

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