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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)
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
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United States of America
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT01194414