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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00476996




Registration number
NCT00476996
Ethics application status
Date submitted
18/05/2007
Date registered
22/05/2007
Date last updated
12/08/2019

Titles & IDs
Public title
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-a Therapy (SCRIPT)
Scientific title
A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-a Therapy
Secondary ID [1] 0 0
WA20495
Secondary ID [2] 0 0
ACT3986g
Universal Trial Number (UTN)
Trial acronym
SCRIPT
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 - Leflunomide
Treatment: Drugs - Methotrexate
Treatment: Drugs - Ocrelizumab
Treatment: Drugs - Ocrelizumab
Treatment: Drugs - Placebo

Experimental: Ocrelizumab 200 mg x 2 IV + Non-Biologic DMARD Therapy - Participants will receive 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD

Experimental: Ocrelizumab 500 mg x 2 IV + Non-Biologic DMARD Therapy - Participants will receive 2 IV infusions of 500 mg of ocrelizumab, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD

Placebo comparator: Placebo x 2 IV + Non-Biologic DMARD Therapy - Participants will receive ocrelizumab matching placebo IV in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD


Treatment: Drugs: Leflunomide
Oral repeating dose

Treatment: Drugs: Methotrexate
Oral or parenteral repeating dose

Treatment: Drugs: Ocrelizumab
Intravenous repeating dose (200mg)

Treatment: Drugs: Ocrelizumab
Intravenous repeating dose (500mg)

Treatment: Drugs: Placebo
Intravenous repeating dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses
Timepoint [1] 0 0
Weeks 24 and 48
Secondary outcome [1] 0 0
Percentage of Participants With a Major Clinical Response
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants Achieving Disease Activity Score (DAS28) Remission
Timepoint [2] 0 0
Weeks 24 and 48
Secondary outcome [3] 0 0
Change in DAS28 From Baseline
Timepoint [3] 0 0
Weeks 24 and 48
Secondary outcome [4] 0 0
Percentage of Participants With EULAR Response Rates of Good/ Moderate
Timepoint [4] 0 0
Weeks 24 and 48
Secondary outcome [5] 0 0
Percentage of Participants Achieving an ACR50 Response
Timepoint [5] 0 0
Weeks 24 and 48
Secondary outcome [6] 0 0
Percentage of Participants Achieving an ACR70 Response
Timepoint [6] 0 0
Weeks 24 and 48
Secondary outcome [7] 0 0
Percentage of Participants With a Reduction in the HAQ-DI Score
Timepoint [7] 0 0
Weeks 24 and 48

Eligibility
Key inclusion criteria
* Adult patients, = 18 years of age
* Rheumatoid arthritis for at least 3 months
* Inadequate response to previous or current treatment with at least one anti-TNF-alpha agent
* Receiving either leflunomide or methotrexate for = 12 weeks, with a stable dose for the last 4 weeks
* Swollen joint count (SJC) = 4 (66 joint count) and tender joint count (TJC) = 4 (68 joint count) at screening and baseline.
* CRP = 0.6 mg/dL using a high-sensitivity assay.
* Positive rheumatoid factor or positive anti-CCP antibody or both.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Rheumatic autoimmune disease or inflammatory joint disease, other than RA
* Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/05/2018
Sample size
Target
Accrual to date
Final
836
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Sunshine Coast Rheumatology Research Unit - Maroochydore
Recruitment hospital [2] 0 0
Princess Alexandra Hospital; Rheumatology - Woolloongabba
Recruitment hospital [3] 0 0
Royal Perth Hospital; Rheumatology - Shenton Park
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
6008 - Shenton Park
Recruitment outside Australia
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United States of America
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Alabama
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Lausanne
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Switzerland
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Zürich
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Taiwan
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Kaohsiung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Roche Pharma AG
Address [1] 0 0
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
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/NCT00476996