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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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- Adelaide
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- Clayton
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- Geelong
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- 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
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Coventry
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Eastbourne
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Exeter
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Harrogate
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Ipswich
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Westcliffe-on-sea
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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/study/NCT01194414
Trial related presentations / publications
Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Bao M, Rowell L, Davies C, Mysler EF. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016 Jan;75(1):68-74. doi: 10.1136/annrheumdis-2015-207281. Epub 2015 Jun 8.
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/study/NCT01194414