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CompletedNCT01399697Updated Jul 13, 2015Results posted

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

A Phase 4 interventional study of methotrexate and methotrexate in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 54 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-13.

Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
261
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 261 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Active moderate to severe rheumatoid arthritis (DAS28 >/= 3.2) at baseline
  • Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
  • Body weight \< 150 kg
  • Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing women
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
  • Rheumatic autoimmune disease other than RA
  • Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
  • Prior history of or current inflammatory joint disease other than RA
  • Treatment with a biologic agent at any time prior to baseline
  • Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Previous treatment with RoActemra/Actemra
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • Known active current or history of recurrent infection
  • History of or currently active primary or secondary immunodeficiency
  • Active tuberculosis requiring treatment within the previous 3 years
  • Positive for HIV infection
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
261 participants (actual)

Study arms

  • Experimental
    A

    Drug: methotrexate · Drug: tocilizumab [RoActemra/Actemra]

  • Active comparator
    B

    Drug: methotrexate · Drug: placebo · Drug: tocilizumab [RoActemra/Actemra]

Interventions

  • Drugmethotrexate

    orally, Week 1 - 16

  • Drugmethotrexate

    orally, Week 17-28

  • Drugplacebo

    methotrexate placebo orally, Week 17-28

  • Drugtocilizumab [RoActemra/Actemra]

    8 mg/kg iv every 4 weeks, 28 weeks

06

What researchers measure

Primary outcomes

  1. Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28

    The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]), and general health status (participant global assessment of disease activity using visual analog scale \[VAS\], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

    Time frame: Baseline, Week 16, and Week 28

Secondary outcomes

  1. Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28

    The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 \<2.6 equals (=) remission.

    Time frame: Week 28

  2. Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28

    CDAI is the sum of tender and swollen joint count based on 28 joints and the participant and physician global disease assessment (VAS 0-10 centimeters \[cm\]). CDAI total score 0-76; higher scores = greater affect due to disease activity. CDAI \<2.8 = clinical remission.

    Time frame: Week 28

  3. Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28

    SDAI is calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligram per deciliter (mg/dL). SDAI total score 0-86; higher scores = greater affect due to disease activity. SDAI \<3.3 = clinical remission.

    Time frame: 28 weeks

  4. Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28

    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Time frame: Week 16 and Week 28

  5. Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health

    Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated decline in health and higher scores indicated improvement in health.

    Time frame: Week 16 and Week 28

  6. Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health

    Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated a worsening of quality of life.

    Time frame: Week 16 and Week 28

  7. Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant

    Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.

    Time frame: Week 16 and Week 28

  8. Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator

    Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.

    Time frame: Week 16 and Week 28

07

Results

Posted Jul 13, 2015

Participant flow

Participant flow — Overall Study
MilestoneTocilizumab (TCZ) Plus (+) Methotrexate (Not Randomized)TCZ + MTX (Randomized)TCZ + Placebo (Randomized)
Started968382
Completed558078
Not completed4134
Withdrew: Adverse event1331
Withdrew: Lost to follow-up200
Withdrew: Withdrawal by subject800
Withdrew: Investigator decisión102
Withdrew: Lack of efficacy901
Withdrew: Protocol violation200
Withdrew: Non-compliant100
Withdrew: Inclusion error200
Withdrew: Positive result for hepatitis b100
Withdrew: Clinical ra remission100
Withdrew: Sponsor decision100

Outcome measures

PrimaryChange in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28

The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]), and general health status (participant global assessment of disease activity using visual analog scale \[VAS\], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

Time frame:
Baseline, Week 16, and Week 28
Reported as:
Mean · units on a scale
Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28
units on a scaleTCZ + MTX (Randomized)TCZ + Placebo (Randomized)
Baseline5.42 ± 1.015.29 ± 1.01
Week 161.77 ± 0.771.96 ± 0.76
Week 281.82 ± 1.181.98 ± 1.13
Statistical analysis
  • TCZ + MTX (Randomized) vs TCZ + Placebo (Randomized) · ANCOVA · p = 0.700
SecondaryPercentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28

The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 \<2.6 equals (=) remission.

Time frame:
Week 28
Reported as:
Number · percentage of participants
Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28
percentage of participantsTCZ + MTX (Randomized)TCZ + Placebo (Randomized)
Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 2882.375.9
Statistical analysis
  • TCZ + MTX (Randomized) vs TCZ + Placebo (Randomized) · Chi-squared · p = 0.328
SecondaryPercentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28

CDAI is the sum of tender and swollen joint count based on 28 joints and the participant and physician global disease assessment (VAS 0-10 centimeters \[cm\]). CDAI total score 0-76; higher scores = greater affect due to disease activity. CDAI \<2.8 = clinical remission.

Time frame:
Week 28
Reported as:
Number · percentage of participants
Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28
percentage of participantsTocilizumab + Methotrexate (Randomized)Tocilizumab + Placebo (Randomized)
Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 2840.735.8
Statistical analysis
  • Tocilizumab + Methotrexate (Randomized) vs Tocilizumab + Placebo (Randomized) · Chi-squared · p = 0.518
SecondaryPercentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28

SDAI is calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligram per deciliter (mg/dL). SDAI total score 0-86; higher scores = greater affect due to disease activity. SDAI \<3.3 = clinical remission.

Time frame:
28 weeks
Reported as:
Number · percentage of participants
Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28
percentage of participantsTCZ + MTX (Randomized)TCZ + Placebo (Randomized)
Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 2835.128.2
Statistical analysis
  • TCZ + MTX (Randomized) vs TCZ + Placebo (Randomized) · Chi-squared · p = 0.358
SecondaryChange in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame:
Week 16 and Week 28
Reported as:
Mean · units on a scale
Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28
units on a scaleTCZ + MTX (Randomized)TCZ + Placebo (Randomized)
Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 280.08 ± 0.470.00 ± 0.52
Statistical analysis
  • TCZ + MTX (Randomized) vs TCZ + Placebo (Randomized) · ANCOVA · p = 0.674 · Difference in least square (ls) mean: 0.032 · 95% CI -0.119 to 0.184Analysis of covariance (ANCOVA) model with treatment as factor and DAS28 value at Week 16 as covariate.
SecondaryChange in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health

Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated decline in health and higher scores indicated improvement in health.

Time frame:
Week 16 and Week 28
Reported as:
Mean · units on a scale
Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health
units on a scaleTCZ + MTX (Randomized)TCZ + Placebo (Randomized)
Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health-2.36 ± 10.22-0.38 ± 9.25
Statistical analysis
  • TCZ + MTX (Randomized) vs TCZ + Placebo (Randomized) · ANCOVA · p = 0.204 · Difference in ls mean: -1.873 · 95% CI -4.775 to 1.030ANCOVA model with treatment as factor and mental component score (MCS) as covariate.
SecondaryChange in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health

Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated a worsening of quality of life.

Time frame:
Week 16 and Week 28
Reported as:
Mean · units on a scale
Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health
units on a scaleTCZ + MTX (Randomized)TCZ + Placebo (Randomized)
Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health0.48 ± 9.49-2.26 ± 8.82
Statistical analysis
  • TCZ + MTX (Randomized) vs TCZ + Placebo (Randomized) · ANCOVA · p = 0.015 · Difference in ls mean: 3.376 · 95% CI 0.676 to 6.076ANCOVA model with treatment as factor and physical component score (PCS) as covariate.
SecondaryChange From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant

Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.

Time frame:
Week 16 and Week 28
Reported as:
Mean · units on a scale
Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant
units on a scaleTCZ + MTX (Randomized)Tocilizumab + Placebo (Randomized)
Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant1.68 ± 23.800.56 ± 20.42
Statistical analysis
  • TCZ + MTX (Randomized) vs Tocilizumab + Placebo (Randomized) · ANCOVA · p = 0.769 · Difference in ls mean: 0.969 · 95% CI -5.526 to 7.464ANCOVA model with treatment as factor and VAS performed by the participant at Week 16 as a covariate.
SecondaryChange From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator

Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.

Time frame:
Week 16 and Week 28
Reported as:
Mean · units on a scale
Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator
units on a scaleTCZ + MTX (Randomized)TCZ + Placebo (Randomized)
Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator2.71 ± 16.962.85 ± 18.48
Statistical analysis
  • TCZ + MTX (Randomized) vs TCZ + Placebo (Randomized) · ANCOVA · p = 0.655 · Difference in ls mean: -1.216 · 95% CI -6.573 to 4.141ANCOVA model with treatment as factor and VAS performed by the investigator at Week 16 as covariate.

Adverse events

Collected over From Day 1 up to Week 36. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TCZ + MTX (Not Randomized)—11/96 (11.5%)28/96 (29.2%)
TCZ + MTX (Pre-randomization)—0/83 (0%)20/83 (24.1%)
TCZ + Placebo (Pre-randomization)—1/82 (1.2%)24/82 (29.3%)
TCZ + MTX (Post-randomization)—1/83 (1.2%)8/83 (9.6%)
TCZ + Placebo (Post-randomization)—4/82 (4.9%)4/82 (4.9%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventTCZ + MTX (Not Randomized)TCZ + MTX (Pre-randomization)TCZ + Placebo (Pre-randomization)TCZ + MTX (Post-randomization)TCZ + Placebo (Post-randomization)
HypertransaminasaemiaHepatobiliary disorders3/960/830/820/830/82
Deep vein thrombosisVascular disorders2/960/830/820/830/82
VertigoEar and labyrinth disorders0/960/830/820/831/82
Bursitis infectiveInfections and infestations0/960/830/820/831/82
PneumoniaInfections and infestations1/960/830/820/831/82
Staphylococcal skin infectionInfections and infestations0/960/830/820/831/82
Respiratory tract infectionInfections and infestations0/960/831/820/830/82
Endocarditis bacterialInfections and infestations0/960/830/821/830/82
Chest PainGeneral disorders1/960/830/820/830/82
Cytomegalovirus infectionInfections and infestations1/960/830/820/830/82
Most frequent other events
Most frequent other events
EventTCZ + MTX (Not Randomized)TCZ + MTX (Pre-randomization)TCZ + Placebo (Pre-randomization)TCZ + MTX (Post-randomization)TCZ + Placebo (Post-randomization)
HypertransaminasaemiaHepatobiliary disorders15/9612/8310/828/834/82
HypercholesterolaemiaMetabolism and nutrition disorders9/962/836/820/830/82
Aphthous stomatitisGastrointestinal disorders0/963/836/820/830/82
LeukopeniaBlood and lymphatic system disorders7/960/830/820/830/82
NeutropeniaBlood and lymphatic system disorders7/960/830/820/830/82
Urinary tract infectionInfections and infestations0/963/835/820/830/82
Respiratory tract infectionInfections and infestations5/960/830/820/830/82

Baseline characteristics

All treated population

Age, Continuous
Age, Continuous(years)TCZ + MTX (Not Randomized)TCZ + MTX (Randomized)TCZ + Placebo (Randomized)Total
Mean52.3 ± 13.250.2 ± 12.551.0 ± 12.251.2 ± 12.6
Sex: Female, Male
Sex: Female, Male(Participants)TCZ + MTX (Not Randomized)TCZ + MTX (Randomized)TCZ + Placebo (Randomized)Total
Female766265203
Male20211758
08

Study locations

54 sites
  • Orihuela, Alicante 03314, Spain
  • Torrevieja, Alicante 03186, Spain
  • Villajoyosa, Alicante 03570, Spain
  • Merida, Badajoz 06800, Spain
  • Badalona, Barcelona 08915, Spain
  • Granollers, Barcelona 08402, Spain
  • Terrassa, Barcelona 08221, Spain
  • Cádiz, Cadiz 11009, Spain
  • Torrelavega, Cantabria 39300, Spain
  • Villarreal, Castellon 12540, Spain
  • Menorca, Islas Baleares 07701, Spain
  • A Coruna, La Coruña 15006, Spain
  • Santiago de Compostela, La Coruña 15706, Spain
  • Las Palmas De Gran Canaria, Las Palmas 35020, Spain
  • Alcala de Henares, Madrid 28805, Spain
  • Fuenlabrada, Madrid 28942, Spain
  • Valdemoro, Madrid 28342, Spain
  • Cartagena, Murcia 30203, Spain
  • El Palmar, Murcia 30120, Spain
  • Vigo, Pontevedra 36214, Spain
  • Manises, Valencia 46940, Spain
  • Valenica, Valencia 46009, Spain
  • Barakaldo, Vizcaya 48903, Spain
  • Bilbao, Vizcaya 48013, Spain
  • Galdakao, Vizcaya 48960, Spain
  • Albacete, 02006, Spain
  • Badajoz, 06080, Spain
  • Barcelona, 08003, Spain
  • Barcelona, 08025, Spain
  • Barcelona, 08035, Spain
  • Barcelona, 08036, Spain
  • Barcelona, 08907, Spain
  • Caceres, 10310, Spain
  • Cordoba, 14004, Spain
  • Granada, 18003, Spain
  • Granada, 18014, Spain
  • Guadalajara, 19002, Spain
  • Leon, 24071, Spain
  • Lugo, 27004, Spain
  • Madrid, 28007, Spain
  • Madrid, 28031, Spain
  • Madrid, 28034, Spain
  • Madrid, 28040, Spain
  • Madrid, 28041, Spain
  • Madrid, 28046, Spain
  • Madrid, 28905, Spain
  • Malaga, 29009, Spain
  • Salamanca, 37007, Spain
  • Sevilla, 41009, Spain
  • Sevilla, 41013, Spain
  • Tenerife, 38010, Spain
  • Toledo, 45004, Spain
  • Valencia, 46010, Spain
  • Valencia, 46017, Spain
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01399697
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jul 22, 2011
Start date
Sep 2011
Primary completion
May 2014
Completion
May 2014
Results posted
Jul 13, 2015
Last update
Jul 13, 2015

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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