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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00410410




Registration number
NCT00410410
Ethics application status
Date submitted
11/12/2006
Date registered
12/12/2006
Date last updated
24/03/2015

Titles & IDs
Public title
A Study of Abatacept in Patients With Active Ulcerative Colitis
Scientific title
A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy
Secondary ID [1] 0 0
IM101-108
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - abatacept (ABA)
Treatment: Drugs - placebo
Treatment: Drugs - abatacept

Experimental: Abatacept (ABA) - Induction Period; 3 arms for Cohort 1: ABA 30/\~10 mg/kg (ABA administered at 30 mg/kg followed by ABA at \~10 mg/kg), ABA \~10 mg/kg, ABA 3 mg/kg

Induction Period; 2 arms for Cohort 2: ABA 30/\~10 mg/kg and Second Cohort ABA \~10 mg/kg

1 arm for maintenance period (ABA \~10 mg/kg)

Placebo comparator: Placebo - 1 arm for induction period

1 arm for maintenance period

Other: abatacept - 1 arm for open-label extension phase (ABA \~10 mg/kg)


Treatment: Drugs: abatacept (ABA)
Dextrose 5% in water, IV. Placebo on days IP-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; 10 mg/kg on days IP-1, IP-15,IP-29, IP-57; or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57 (ABA 30/\~10 mg/kg Group).

Induction Period 3 months

Maintenance Period 12 months

Treatment: Drugs: placebo
Normal saline, IV, 0 mg/kg, every 28 days.

Induction Period 3 months

Maintenance Period 12 months

Treatment: Drugs: abatacept
\~10 mg/kg, once monthly

Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C)
Timepoint [1] 0 0
Week 12 (Day IP-85)
Primary outcome [2] 0 0
Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12
Timepoint [2] 0 0
Month 12 (Day MP-365)
Primary outcome [3] 0 0
Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation
Timepoint [3] 0 0
Day OL-1 through the end of the OL
Primary outcome [4] 0 0
OL; Number of Participants With AEs of Special Interest
Timepoint [4] 0 0
Day OL-1 through Day OL-729
Primary outcome [5] 0 0
OL; Number of Participants With Physical Examination Findings
Timepoint [5] 0 0
Day OL-1 through Day OL-729
Primary outcome [6] 0 0
OL; Number of Participants With Marked Hematology Laboratory Abnormalities
Timepoint [6] 0 0
Day OL-1 through Day OL-729
Primary outcome [7] 0 0
OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities
Timepoint [7] 0 0
Day OL-1 through Day OL-729
Primary outcome [8] 0 0
OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities
Timepoint [8] 0 0
Day OL-1 through Day OL-729
Secondary outcome [1] 0 0
IP; Baseline Mayo Score: IP1C
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C
Timepoint [2] 0 0
Week 12 (Day IP-85)
Secondary outcome [3] 0 0
IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C
Timepoint [3] 0 0
Week 12 (Day IP-85)
Secondary outcome [4] 0 0
IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C
Timepoint [4] 0 0
Week 12 (Day IP-85)
Secondary outcome [5] 0 0
IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C
Timepoint [6] 0 0
Baseline (Day IP-1), Day IP-85 (Week 12)
Secondary outcome [7] 0 0
IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (=1 Point) at Week 12: IP1C
Timepoint [7] 0 0
Day IP-85 (Week 12)
Secondary outcome [8] 0 0
IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (=1 Point) at Week 12: IP1C
Timepoint [8] 0 0
Day IP-85 (Week 12)
Secondary outcome [9] 0 0
IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (=1 Point) at Week 12: IP1C
Timepoint [9] 0 0
Day IP-85 (Week 12)
Secondary outcome [10] 0 0
IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With Clinical Response At Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C
Timepoint [10] 0 0
Week 12 (Day IP-85)
Secondary outcome [11] 0 0
IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C
Timepoint [11] 0 0
Week 12 (Day IP-85)
Secondary outcome [12] 0 0
IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C
Timepoint [12] 0 0
Week 12 (Day IP-85)
Secondary outcome [13] 0 0
IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C
Timepoint [13] 0 0
Week 12 (Day IP-85)
Secondary outcome [14] 0 0
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C
Timepoint [14] 0 0
Day IP-1 through Day IP-85
Secondary outcome [15] 0 0
IP; Number of Participants With AEs Of Special Interest: IP1C + IP2C
Timepoint [15] 0 0
Day IP-1 through Day IP-85
Secondary outcome [16] 0 0
IP; Number of Participants With Physical Examination Findings: IP1C + IP2C
Timepoint [16] 0 0
Day IP-1 through Day IP-85
Secondary outcome [17] 0 0
IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C
Timepoint [17] 0 0
Day IP-1 through Day IP-85
Secondary outcome [18] 0 0
IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C
Timepoint [18] 0 0
Day IP-1 through Day IP-85
Secondary outcome [19] 0 0
IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C
Timepoint [19] 0 0
Day IP-1 through Day IP-85
Secondary outcome [20] 0 0
IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C
Timepoint [20] 0 0
Day IP-1 through Day IP-85
Secondary outcome [21] 0 0
IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C
Timepoint [21] 0 0
Day IP-1 through Day IP-85
Secondary outcome [22] 0 0
IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C
Timepoint [22] 0 0
For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85). For participants treated in OL directly after IP: Day IP-1 to Day OL-1. For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)
Secondary outcome [23] 0 0
MP; Number of Participants in Clinical Remission at Month 12
Timepoint [23] 0 0
Month 12 (Day MP-365)
Secondary outcome [24] 0 0
MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (=1 Point) at Month 12
Timepoint [24] 0 0
Month 12 (Day MP-365)
Secondary outcome [25] 0 0
MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12
Timepoint [25] 0 0
Month 6 (Day MP-169), Month 12 (Day MP-365)
Secondary outcome [26] 0 0
MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12
Timepoint [26] 0 0
Day MP-365 (Month 12)
Secondary outcome [27] 0 0
MP; Mean Change From Baseline to Month 12 in IBDQ
Timepoint [27] 0 0
Day MP-365
Secondary outcome [28] 0 0
MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36)
Timepoint [28] 0 0
Day MP-365
Secondary outcome [29] 0 0
MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12
Timepoint [29] 0 0
Day MP-365 (Month 12)
Secondary outcome [30] 0 0
MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (=1 Point) at Month 12
Timepoint [30] 0 0
Day MP-365 (Month 12)
Secondary outcome [31] 0 0
MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (=1 Point) at Month 12
Timepoint [31] 0 0
Day MP-365 (Month 12)
Secondary outcome [32] 0 0
MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (=1 Point) at Month 12
Timepoint [32] 0 0
Day MP-365 (Month 12)
Secondary outcome [33] 0 0
MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)
Timepoint [33] 0 0
Month 12 (Day MP-365)
Secondary outcome [34] 0 0
MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)
Timepoint [34] 0 0
Month 12 (Day MP-365)
Secondary outcome [35] 0 0
MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)
Timepoint [35] 0 0
Month 12 (Day MP-365)
Secondary outcome [36] 0 0
MP; Number of Participants With Abatacept-Induced Antibodies
Timepoint [36] 0 0
For participants not entering OL: All measurements starting after Day MP-1 (including follow-up visits). For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1).
Secondary outcome [37] 0 0
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation
Timepoint [37] 0 0
Day MP-1 through Day MP-365
Secondary outcome [38] 0 0
MP; Number of Participants With AEs of Special Interest
Timepoint [38] 0 0
Day MP-1 through Day MP-365
Secondary outcome [39] 0 0
MP; Number of Participants With Physical Examination Findings
Timepoint [39] 0 0
Day IP-85 through Day MP-365
Secondary outcome [40] 0 0
MP; Number of Participants With Marked Hematology Laboratory Abnormalities
Timepoint [40] 0 0
Day IP-85 through Day MP-365
Secondary outcome [41] 0 0
MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities
Timepoint [41] 0 0
Day IP-85 through Day MP-365
Secondary outcome [42] 0 0
OL; Number of Participants With Clinical Response Over Time
Timepoint [42] 0 0
Day OL-1 through Day OL-729
Secondary outcome [43] 0 0
OL; Number of Participants With Clinical Remission Over Time
Timepoint [43] 0 0
Day OL-1 through Day OL-729
Secondary outcome [44] 0 0
OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (=1 Point) During OL
Timepoint [44] 0 0
Open-Label Period (Day OL-1 through Day OL-729)
Secondary outcome [45] 0 0
OL; Number of Participants With Clinical Response or Clinical Remission Upon Retreatment With Abatacept Among Those Who Received Abatacept in the IP or MP Period
Timepoint [45] 0 0
Last Study Visit (Day OL-729)
Secondary outcome [46] 0 0
OL; Number of Participants With Abatacept-Induced Antibodies
Timepoint [46] 0 0
For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)
Secondary outcome [47] 0 0
OL; Number of Participants Using Corticosteroids During OL
Timepoint [47] 0 0
Day OL-1 through Day OL-729

Eligibility
Key inclusion criteria
* Men or women 18 years or older
* Ulcerative colitis for at lease 3 months
* Moderate to severe active ulcerative colitis
* Inadequate response or intolerance to standard ulcerative colitis treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
Accrual to date
Final
591
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Camperdown
Recruitment hospital [3] 0 0
Local Institution - Herston
Recruitment hospital [4] 0 0
Local Institution - South Brisbane
Recruitment hospital [5] 0 0
Local Institution - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - Launceston
Recruitment hospital [7] 0 0
Local Institution - Box Hill
Recruitment hospital [8] 0 0
Local Institution - Fitzroy
Recruitment hospital [9] 0 0
Local Institution - South Ballarat
Recruitment hospital [10] 0 0
Local Institution - Fremantle
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
7250 - Launceston
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3065 VIC - Fitzroy
Recruitment postcode(s) [9] 0 0
3350 - South Ballarat
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Belgium
State/province [25] 0 0
Bruxelles
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
Country [27] 0 0
Brazil
State/province [27] 0 0
Bahia
Country [28] 0 0
Brazil
State/province [28] 0 0
Goias
Country [29] 0 0
Brazil
State/province [29] 0 0
Parana
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio Grande Do Sul
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio De Janeiro
Country [33] 0 0
Canada
State/province [33] 0 0
British Columbia
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Brno - Bohunice
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Ceske Budejovice
Country [38] 0 0
France
State/province [38] 0 0
Amiens Cedex 1
Country [39] 0 0
France
State/province [39] 0 0
Clichy
Country [40] 0 0
France
State/province [40] 0 0
Lille Cedex
Country [41] 0 0
France
State/province [41] 0 0
Nice
Country [42] 0 0
France
State/province [42] 0 0
Paris
Country [43] 0 0
France
State/province [43] 0 0
Pessac
Country [44] 0 0
France
State/province [44] 0 0
Toulouse
Country [45] 0 0
Germany
State/province [45] 0 0
Kiel
Country [46] 0 0
Germany
State/province [46] 0 0
Muenster
Country [47] 0 0
India
State/province [47] 0 0
Andhra Pradesh
Country [48] 0 0
India
State/province [48] 0 0
Kerala
Country [49] 0 0
India
State/province [49] 0 0
Maharashtra
Country [50] 0 0
India
State/province [50] 0 0
Bangalore
Country [51] 0 0
India
State/province [51] 0 0
Delhi
Country [52] 0 0
India
State/province [52] 0 0
Hyderabad
Country [53] 0 0
India
State/province [53] 0 0
Mangalore
Country [54] 0 0
India
State/province [54] 0 0
Manipal
Country [55] 0 0
India
State/province [55] 0 0
Mumbai
Country [56] 0 0
India
State/province [56] 0 0
Mysore
Country [57] 0 0
Ireland
State/province [57] 0 0
Dublin
Country [58] 0 0
Italy
State/province [58] 0 0
Napoli
Country [59] 0 0
Italy
State/province [59] 0 0
Padova
Country [60] 0 0
Italy
State/province [60] 0 0
Roma
Country [61] 0 0
Italy
State/province [61] 0 0
San Giovanni Rotondo
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Seoul
Country [63] 0 0
Mexico
State/province [63] 0 0
Coahuila
Country [64] 0 0
Mexico
State/province [64] 0 0
Distrito Federal
Country [65] 0 0
Mexico
State/province [65] 0 0
Jalisco
Country [66] 0 0
Mexico
State/province [66] 0 0
Nuevo Leon
Country [67] 0 0
Mexico
State/province [67] 0 0
Sinaloa
Country [68] 0 0
Mexico
State/province [68] 0 0
Sonora
Country [69] 0 0
Mexico
State/province [69] 0 0
Chihuahua
Country [70] 0 0
Netherlands
State/province [70] 0 0
Amersfoort
Country [71] 0 0
Netherlands
State/province [71] 0 0
Amsterdam
Country [72] 0 0
Netherlands
State/province [72] 0 0
Groningen
Country [73] 0 0
Poland
State/province [73] 0 0
Katowice
Country [74] 0 0
Poland
State/province [74] 0 0
Warszawa
Country [75] 0 0
Poland
State/province [75] 0 0
Wroclaw
Country [76] 0 0
Puerto Rico
State/province [76] 0 0
Ponce
Country [77] 0 0
South Africa
State/province [77] 0 0
Gauteng
Country [78] 0 0
South Africa
State/province [78] 0 0
Kwa Zulu Natal
Country [79] 0 0
South Africa
State/province [79] 0 0
Western Cape
Country [80] 0 0
Switzerland
State/province [80] 0 0
Bern
Country [81] 0 0
Switzerland
State/province [81] 0 0
Zuerich
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Greater London
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Oxfordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00410410