Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01194414




Registration number
NCT01194414
Ethics application status
Date submitted
1/09/2010
Date registered
3/09/2010
Date last updated
20/06/2016

Titles & IDs
Public title
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis
Scientific title
A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis
Secondary ID [1] 0 0
2010-018375-22
Secondary ID [2] 0 0
WA22762
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tocilizumab SC
Treatment: Drugs - tocilizumab IV
Treatment: Drugs - placebo to tocilizumab SC
Treatment: Drugs - placebo to tocilizumab IV
Treatment: Drugs - Disease-modifying antirheumatic drugs (DMARDs)

Experimental: Tocilizumab SC - Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.

Experimental: Tocilizumab IV - Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.

Experimental: Tocilizumab SC Then Tocilizumab IV - Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.

Experimental: Tocilizumab IV Then Tocilizumab SC - Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.


Treatment: Drugs: tocilizumab SC
Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.

Treatment: Drugs: tocilizumab IV
Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.

Treatment: Drugs: placebo to tocilizumab SC
Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period.

Treatment: Drugs: placebo to tocilizumab IV
Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period.

Treatment: Drugs: Disease-modifying antirheumatic drugs (DMARDs)
stable dose as prescribed
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24
Timepoint [1] 0 0
Baseline, 24 weeks
Primary outcome [2] 0 0
Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments
Timepoint [2] 0 0
Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
Secondary outcome [1] 0 0
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24
Timepoint [1] 0 0
Baseline, 24 weeks
Secondary outcome [2] 0 0
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24
Timepoint [2] 0 0
Baseline, 24 weeks
Secondary outcome [3] 0 0
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants Achieving a Decrease of = 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24
Timepoint [4] 0 0
Baseline, 24 Weeks
Secondary outcome [5] 0 0
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24
Timepoint [5] 0 0
24 Weeks
Secondary outcome [6] 0 0
Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97
Timepoint [6] 0 0
Week 97
Secondary outcome [7] 0 0
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97
Timepoint [7] 0 0
Week 97
Secondary outcome [8] 0 0
Percentage of Participants Achieving a Decrease of =0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97
Timepoint [8] 0 0
Baseline, Week 97
Secondary outcome [9] 0 0
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97
Timepoint [9] 0 0
Week 97
Secondary outcome [10] 0 0
Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion
Timepoint [10] 0 0
Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose
Secondary outcome [11] 0 0
Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment
Timepoint [11] 0 0
Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose.
Secondary outcome [12] 0 0
Minimum Serum Concentration (Cmin) of Tocilizumab
Timepoint [12] 0 0
Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose
Secondary outcome [13] 0 0
Maximum Serum Concentration (Cmax) of Tocilizumab
Timepoint [13] 0 0
Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose
Secondary outcome [14] 0 0
Time to Maximum Serum Concentration (Tmax) of Tocilizumab
Timepoint [14] 0 0
Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose
Secondary outcome [15] 0 0
Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25
Timepoint [15] 0 0
Baseline, Week 25
Secondary outcome [16] 0 0
Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97
Timepoint [16] 0 0
Baseline, Week 97
Secondary outcome [17] 0 0
Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97
Timepoint [17] 0 0
Week 97

Eligibility
Key inclusion criteria
- Adult participants, = 18 years of age

- Rheumatoid arthritis of = 6 months duration, according to American College of
Rheumatology (ACR) criteria

- Swollen joint count (SJC) = 4 (66 joint count), tender joint count (TJC) = 4 (68 joint
count) at screening and baseline

- Inadequate response to current DMARD therapy

- Permitted DMARDs must be at stable dose for = 8 weeks prior to baseline

- Oral corticosteroids (= 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum
recommended dose) must be at stable dose for = 4 weeks prior to baseline
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization

- Rheumatic autoimmune disease other than RA

- Functional class IV (ACR classification)

- Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis
(JRA) and/or RA before the age of 16

- Prior history of or current inflammatory joint disease other than RA

- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline

- Previous treatment with tocilizumab

- Active current or history of recurrent infection

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 assessing the outcomes
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
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
1262
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Geelong
Recruitment hospital [4] 0 0
- Hobart
Recruitment hospital [5] 0 0
- Malvern East
Recruitment hospital [6] 0 0
- Maroochydore
Recruitment hospital [7] 0 0
- New Lambton
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
5041 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3145 - Malvern East
Recruitment postcode(s) [7] 0 0
4558 - Maroochydore
Recruitment postcode(s) [8] 0 0
2305 - New Lambton
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
Idaho
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
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Hampshire
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 Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Argentina
State/province [26] 0 0
Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Rosario
Country [28] 0 0
Brazil
State/province [28] 0 0
Curitiba
Country [29] 0 0
Brazil
State/province [29] 0 0
Goiania
Country [30] 0 0
Brazil
State/province [30] 0 0
Juiz de Fora
Country [31] 0 0
Brazil
State/province [31] 0 0
Porto Alegre
Country [32] 0 0
Brazil
State/province [32] 0 0
Sao Paulo
Country [33] 0 0
Brazil
State/province [33] 0 0
São Paulo
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Sofia
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
British Columbia
Country [37] 0 0
Canada
State/province [37] 0 0
Newfoundland and Labrador
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Canada
State/province [40] 0 0
Saskatchewan
Country [41] 0 0
Colombia
State/province [41] 0 0
Barranquilla
Country [42] 0 0
Colombia
State/province [42] 0 0
Bogota
Country [43] 0 0
Colombia
State/province [43] 0 0
Bogotá
Country [44] 0 0
France
State/province [44] 0 0
Bordeaux
Country [45] 0 0
France
State/province [45] 0 0
Le Mans
Country [46] 0 0
France
State/province [46] 0 0
Marseille
Country [47] 0 0
France
State/province [47] 0 0
Montpellier
Country [48] 0 0
France
State/province [48] 0 0
Nantes
Country [49] 0 0
France
State/province [49] 0 0
Paris
Country [50] 0 0
France
State/province [50] 0 0
Strasbourg
Country [51] 0 0
France
State/province [51] 0 0
Toulouse
Country [52] 0 0
Germany
State/province [52] 0 0
Bad Bramstedt
Country [53] 0 0
Germany
State/province [53] 0 0
Berlin
Country [54] 0 0
Germany
State/province [54] 0 0
Dresden
Country [55] 0 0
Germany
State/province [55] 0 0
Essen
Country [56] 0 0
Germany
State/province [56] 0 0
Freiburg
Country [57] 0 0
Germany
State/province [57] 0 0
Gommern
Country [58] 0 0
Germany
State/province [58] 0 0
Heidelberg
Country [59] 0 0
Germany
State/province [59] 0 0
Herne
Country [60] 0 0
Germany
State/province [60] 0 0
Hildesheim
Country [61] 0 0
Germany
State/province [61] 0 0
Köln
Country [62] 0 0
Germany
State/province [62] 0 0
Ludwigshafen
Country [63] 0 0
Germany
State/province [63] 0 0
Osnabrück
Country [64] 0 0
Germany
State/province [64] 0 0
Ratingen
Country [65] 0 0
Germany
State/province [65] 0 0
Rostock
Country [66] 0 0
Germany
State/province [66] 0 0
Würzburg
Country [67] 0 0
Guatemala
State/province [67] 0 0
Guatemala City
Country [68] 0 0
Hong Kong
State/province [68] 0 0
Hong Kong
Country [69] 0 0
Italy
State/province [69] 0 0
Arenzano
Country [70] 0 0
Italy
State/province [70] 0 0
Bergamo
Country [71] 0 0
Italy
State/province [71] 0 0
Catania
Country [72] 0 0
Italy
State/province [72] 0 0
Cona (ferrara)
Country [73] 0 0
Italy
State/province [73] 0 0
Genova
Country [74] 0 0
Italy
State/province [74] 0 0
Napoli
Country [75] 0 0
Italy
State/province [75] 0 0
Pavia
Country [76] 0 0
Italy
State/province [76] 0 0
Pisa
Country [77] 0 0
Italy
State/province [77] 0 0
Potenza
Country [78] 0 0
Italy
State/province [78] 0 0
Reggio Emilia
Country [79] 0 0
Italy
State/province [79] 0 0
Udine
Country [80] 0 0
Italy
State/province [80] 0 0
Varese
Country [81] 0 0
Lithuania
State/province [81] 0 0
Klaipeda
Country [82] 0 0
Lithuania
State/province [82] 0 0
Siauliai
Country [83] 0 0
Lithuania
State/province [83] 0 0
Vilnius
Country [84] 0 0
Mexico
State/province [84] 0 0
Culiacan
Country [85] 0 0
Mexico
State/province [85] 0 0
Guadalajara
Country [86] 0 0
Mexico
State/province [86] 0 0
Leon
Country [87] 0 0
Mexico
State/province [87] 0 0
Merida
Country [88] 0 0
Mexico
State/province [88] 0 0
Mexico Ctiy
Country [89] 0 0
Mexico
State/province [89] 0 0
Miexico City
Country [90] 0 0
Mexico
State/province [90] 0 0
Morelia
Country [91] 0 0
Mexico
State/province [91] 0 0
Obregon
Country [92] 0 0
Mexico
State/province [92] 0 0
Queretaro
Country [93] 0 0
Mexico
State/province [93] 0 0
Saltillo
Country [94] 0 0
Mexico
State/province [94] 0 0
Torreon
Country [95] 0 0
New Zealand
State/province [95] 0 0
Auckland
Country [96] 0 0
New Zealand
State/province [96] 0 0
Hamilton
Country [97] 0 0
New Zealand
State/province [97] 0 0
Tauranga
Country [98] 0 0
New Zealand
State/province [98] 0 0
Wellington
Country [99] 0 0
Peru
State/province [99] 0 0
Lima 01
Country [100] 0 0
Peru
State/province [100] 0 0
Lima
Country [101] 0 0
Philippines
State/province [101] 0 0
Cebu
Country [102] 0 0
Philippines
State/province [102] 0 0
Manila
Country [103] 0 0
Philippines
State/province [103] 0 0
Quezon
Country [104] 0 0
Poland
State/province [104] 0 0
Bialystok
Country [105] 0 0
Poland
State/province [105] 0 0
Lublin
Country [106] 0 0
Poland
State/province [106] 0 0
Poznan
Country [107] 0 0
Poland
State/province [107] 0 0
Warszawa
Country [108] 0 0
Puerto Rico
State/province [108] 0 0
Ponce
Country [109] 0 0
Romania
State/province [109] 0 0
Bucharest
Country [110] 0 0
Romania
State/province [110] 0 0
Bucuresti
Country [111] 0 0
Romania
State/province [111] 0 0
Iasi
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Moscow
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Novosibirsk
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Ryazan
Country [115] 0 0
Russian Federation
State/province [115] 0 0
St Petersburg
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Ulyanovsk
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Yaroslavl
Country [118] 0 0
Singapore
State/province [118] 0 0
Singapore
Country [119] 0 0
South Africa
State/province [119] 0 0
Cape Town
Country [120] 0 0
South Africa
State/province [120] 0 0
Durban
Country [121] 0 0
South Africa
State/province [121] 0 0
Parktown
Country [122] 0 0
South Africa
State/province [122] 0 0
Port Elizabeth
Country [123] 0 0
South Africa
State/province [123] 0 0
Stellenbosch
Country [124] 0 0
Spain
State/province [124] 0 0
Barakaldo
Country [125] 0 0
Spain
State/province [125] 0 0
Bilbao
Country [126] 0 0
Spain
State/province [126] 0 0
La Coruna
Country [127] 0 0
Spain
State/province [127] 0 0
La Laguna
Country [128] 0 0
Spain
State/province [128] 0 0
Madrid
Country [129] 0 0
Spain
State/province [129] 0 0
Malaga
Country [130] 0 0
Spain
State/province [130] 0 0
Merida
Country [131] 0 0
Spain
State/province [131] 0 0
Santander
Country [132] 0 0
Spain
State/province [132] 0 0
Santiago de Compostela
Country [133] 0 0
Spain
State/province [133] 0 0
Sevilla
Country [134] 0 0
Spain
State/province [134] 0 0
Torrelavega
Country [135] 0 0
Spain
State/province [135] 0 0
Valencia
Country [136] 0 0
Thailand
State/province [136] 0 0
Bangkok
Country [137] 0 0
Thailand
State/province [137] 0 0
Chiang Mai
Country [138] 0 0
Thailand
State/province [138] 0 0
Khon Kaen
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Cambridge
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Cannock
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Coventry
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Eastbourne
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Exeter
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Harrogate
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Ipswich
Country [146] 0 0
United Kingdom
State/province [146] 0 0
London
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Middlesborough
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Newcastle Upon Tyne
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Northampton
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Nottingham
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Westcliffe-on-sea
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This randomized, double-blind, parallel group study compares the efficacy and safety of
subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with
moderate to severe active rheumatoid arthritis. Participants were randomized to receive
either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv
every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24.
The double-blind period was followed by a 72-week open-label treatment with some switching of
sc and iv administration. No placebo was administered in the open-label phase. Participants
continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout
the study. Anticipated time on study treatment was 2 years.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01194414
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01194414