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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01500278




Registration number
NCT01500278
Ethics application status
Date submitted
22/12/2011
Date registered
28/12/2011
Date last updated
31/07/2018

Titles & IDs
Public title
Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate
Scientific title
A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate
Secondary ID [1] 0 0
2011-002067-20
Secondary ID [2] 0 0
RA0077
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Certolizumab Pegol (CZP)
Treatment: Other - Adalimumab (ADA)
Treatment: Drugs - Methotrexate (MTX)

Active comparator: Certolizumab Pegol + Methotrexate (CZP + MTX) -

Active comparator: Adalimumab + Methotrexate (ADA + MTX) -

Active comparator: CZP + MTX followed by ADA + MTX - Those subjects who received Certolizumab Pegol (400 mg at Weeks 0, 2, 4 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) at Baseline and are Non-Responders at Week 12, switch to Adalimumab (40 mg) + Methotrexate (ADA + MTX) after Week 12.

Active comparator: ADA + MTX followed by CZP + MTX - Those subjects who received Adalimumab (40 mg + Placebo at Weeks 0, 2, 4 followed by 40 mg ADA every two weeks) + Methotrexate (ADA+ MTX) at Baseline and are Non-Responders at Week 12, switch to Certolizumab Pegol (400 mg at Weeks 12, 14, 16 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) after Week 12.


Treatment: Other: Certolizumab Pegol (CZP)
* Active substance: an injectable volume of 1 ml solution for injection CZP
* Pharmaceutical form: prefilled syringes CZP
* Concentration: 200 mg/ml CZP
* Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.

Treatment: Other: Adalimumab (ADA)
* Active substance: an injectable volume of 0.8 ml solution for injection ADA
* Pharmaceutical form: prefilled syringes ADA
* Concentration: 40 mg/0.8 ml ADA
* Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.

Treatment: Drugs: Methotrexate (MTX)
* Active substance: Methotrexate
* Pharmaceutical form: oral tablet
* Concentration: 15-25 mg/week
* Route of Administration: MTX orally
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12
Assessment method [1] 0 0
Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 104
Assessment method [2] 0 0
DAS28 \[ESR\] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v (TJC) + 0.28 x v (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Timepoint [2] 0 0
Week 104
Secondary outcome [1] 0 0
Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 104
Assessment method [1] 0 0
DAS28 \[ESR\] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v (TJC) + 0.28 x v (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity. The definition of Week 12 responders was DAS28\[ESR\] Low Disease Activity (LDA) (ie = 3.2) or an improvement of = 1.2 in DAS28\[ESR\] relative to Baseline.
Timepoint [1] 0 0
Week 104
Secondary outcome [2] 0 0
Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6
Assessment method [2] 0 0
Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
Timepoint [2] 0 0
Week 6
Secondary outcome [3] 0 0
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 6
Assessment method [3] 0 0
DAS28 \[ESR\] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v (TJC) + 0.28 x v (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Timepoint [3] 0 0
Week 6
Secondary outcome [4] 0 0
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 12
Assessment method [4] 0 0
DAS28 \[ESR\] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v (TJC) + 0.28 x v (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12
Assessment method [5] 0 0
DAS28 \[ESR\] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x v (TJC) + 0.28 x v (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity. The definition of Week 6/12 responders was DAS28\[ESR\] Low Disease Activity (LDA) (ie = 3.2) or an improvement of = 1.2 in DAS28\[ESR\] relative to Baseline.
Timepoint [5] 0 0
Week 104
Secondary outcome [6] 0 0
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104
Assessment method [6] 0 0
HAQ-DI was derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), and the total HAQ-DI was scored on the scale of 0-3 as well. Change from Baseline was computed as the value at Week 104 minus the Baseline value. A negative value in Change from Baseline indicates an improvement.
Timepoint [6] 0 0
From Baseline to Week 104
Secondary outcome [7] 0 0
Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12
Assessment method [7] 0 0
Response at Week 12 means that a subject had either a Disease Activity Score 28 \[Erythrocyte Sedimentation Rate\] (DAS28 \[ESR\]) = 3.2 at Week 12 or had a reduction of DAS28 \[ESR\] = 1.2 from Baseline to Week 12. Kaplan-Meier Estimates of Proportion of Subjects Discontinued are presented per study week (days relative to Week 12 visit).
Timepoint [7] 0 0
From Week 12 up to Week 104

Eligibility
Key inclusion criteria
* Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined by the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aletaha D et al, 2010)
* Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at Screening
* Subject must have moderate to severe RA disease at Screening and Baseline defined as:

1. Screening (all criteria required)

* = 4 swollen joints (of 28 prespecified joints)
* Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2
* C-Reactive Protein (CRP) concentration = 10 mg/L (or 1.0 mg/dL) or Erythrocyte Sedimentation Rate (ESR) (Westergren) = 28 mm/hr
2. Baseline (both criteria required)

* = 4 swollen joints (of 28 prespecified joints)
* Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2
* Subject must have inadequately responded previously to Methotrexate (MTX)
* Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has used the same MTX regimen for a minimum of 28 days prior to Baseline
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has previously received any biological Disease Modifying Antirheumatic Drug (DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase, phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine kinase
* Diagnosis of any other inflammatory arthritis
* Infected with Tuberculosis (TB) or high risk of acquiring TB infection
* Subjects with concurrent acute or chronic viral hepatitis B or C infection
* Subjects with a history of chronic or recurrent infections or subjects at high risk of infection
* Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological DMARDs excluding study medications, experimental therapy, IA hyaluronic acid

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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
915
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
6 - Camperdown
Recruitment hospital [2] 0 0
5 - Kogarah
Recruitment hospital [3] 0 0
2 - Maroochydore
Recruitment hospital [4] 0 0
4 - Hobart
Recruitment hospital [5] 0 0
7 - Clayton
Recruitment hospital [6] 0 0
8 - Fitzroy
Recruitment hospital [7] 0 0
1 - Malvern
Recruitment hospital [8] 0 0
3 - Subiaco
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Maroochydore
Recruitment postcode(s) [4] 0 0
- Hobart
Recruitment postcode(s) [5] 0 0
- Clayton
Recruitment postcode(s) [6] 0 0
- Fitzroy
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Subiaco
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
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
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
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
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
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Nebraska
Country [14] 0 0
United States of America
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Nevada
Country [15] 0 0
United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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Ohio
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United States of America
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Oklahoma
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
West Virginia
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United States of America
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Wisconsin
Country [28] 0 0
Austria
State/province [28] 0 0
Stockerau
Country [29] 0 0
Austria
State/province [29] 0 0
Wien
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Pleven
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
Newfoundland and Labrador
Country [35] 0 0
Canada
State/province [35] 0 0
Nova Scotia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Canada
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Barrie
Country [39] 0 0
Czechia
State/province [39] 0 0
Brno
Country [40] 0 0
Czechia
State/province [40] 0 0
Hradec Kralove
Country [41] 0 0
Czechia
State/province [41] 0 0
Plzen
Country [42] 0 0
Czechia
State/province [42] 0 0
Praha
Country [43] 0 0
Czechia
State/province [43] 0 0
Uherske Hradiste
Country [44] 0 0
France
State/province [44] 0 0
Brest
Country [45] 0 0
France
State/province [45] 0 0
Le Mans
Country [46] 0 0
France
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Lyon
Country [47] 0 0
France
State/province [47] 0 0
Montpellier Cedex 5
Country [48] 0 0
France
State/province [48] 0 0
Orleans
Country [49] 0 0
France
State/province [49] 0 0
Toulouse Cedex 9
Country [50] 0 0
Germany
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Berlin
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Germany
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Fulda
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Köln
Country [56] 0 0
Germany
State/province [56] 0 0
Osnabrück
Country [57] 0 0
Germany
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Ratingen
Country [58] 0 0
Germany
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Rheine
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Germany
State/province [59] 0 0
Rostock
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Germany
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Traunstein
Country [61] 0 0
Germany
State/province [61] 0 0
Zerbst
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Greece
State/province [62] 0 0
Heraklion
Country [63] 0 0
Greece
State/province [63] 0 0
Larisa
Country [64] 0 0
Hungary
State/province [64] 0 0
Budapest
Country [65] 0 0
Hungary
State/province [65] 0 0
Gyula
Country [66] 0 0
Hungary
State/province [66] 0 0
Kistarcsa
Country [67] 0 0
Hungary
State/province [67] 0 0
Szeged
Country [68] 0 0
Hungary
State/province [68] 0 0
Veszprem
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Ireland
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Dublin
Country [70] 0 0
Ireland
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Limerick
Country [71] 0 0
Italy
State/province [71] 0 0
Bergamo
Country [72] 0 0
Italy
State/province [72] 0 0
Genova
Country [73] 0 0
Italy
State/province [73] 0 0
Magenta
Country [74] 0 0
Italy
State/province [74] 0 0
Napoli
Country [75] 0 0
Italy
State/province [75] 0 0
Prato
Country [76] 0 0
Italy
State/province [76] 0 0
Roma
Country [77] 0 0
Italy
State/province [77] 0 0
Verona
Country [78] 0 0
Mexico
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Chihuahua
Country [79] 0 0
Mexico
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Guadalajara
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Mexico
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Monterrey
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Mexico
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San Luis Potosi
Country [82] 0 0
Monaco
State/province [82] 0 0
Monaco
Country [83] 0 0
Poland
State/province [83] 0 0
Bydgoszcz
Country [84] 0 0
Poland
State/province [84] 0 0
Poznan
Country [85] 0 0
Poland
State/province [85] 0 0
Warszawa
Country [86] 0 0
Poland
State/province [86] 0 0
Wroclaw
Country [87] 0 0
Portugal
State/province [87] 0 0
Coimbra
Country [88] 0 0
Portugal
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Lisboa
Country [89] 0 0
Portugal
State/province [89] 0 0
Lisbon
Country [90] 0 0
Portugal
State/province [90] 0 0
Ponte De Lima
Country [91] 0 0
Portugal
State/province [91] 0 0
Porto
Country [92] 0 0
Romania
State/province [92] 0 0
Bacau
Country [93] 0 0
Romania
State/province [93] 0 0
Braila
Country [94] 0 0
Romania
State/province [94] 0 0
Bucharest
Country [95] 0 0
Romania
State/province [95] 0 0
Cluj-Napoca
Country [96] 0 0
Romania
State/province [96] 0 0
Galati
Country [97] 0 0
Romania
State/province [97] 0 0
Iasi
Country [98] 0 0
Spain
State/province [98] 0 0
A Coruna
Country [99] 0 0
Spain
State/province [99] 0 0
Madrid
Country [100] 0 0
Spain
State/province [100] 0 0
Sabadell
Country [101] 0 0
Spain
State/province [101] 0 0
Vigo
Country [102] 0 0
Switzerland
State/province [102] 0 0
St. Gallen
Country [103] 0 0
Switzerland
State/province [103] 0 0
Zürich
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Ashford
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Brighton
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Leeds
Country [107] 0 0
United Kingdom
State/province [107] 0 0
London
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Poole
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Sheffield
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Upton
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma SA
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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

TypeCitations or Other Details
Journal Smolen JS, Burmester GR, Combe B, Curtis JR, Hall ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01500278