A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2007-005759-41-GB
• Date of registration: 29/02/2008
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE
• Scientific title: A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE
• Date of first enrolment: 29/04/2008
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005759-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Patients must meet the following criteria to be eligible for study
entry:
1. Ability and willingness to provide written informed consent
and to comply with the requirements of the protocol
2. Age = 18 years
3. Current treatment for RA on an outpatient basis
4. Active disease, defined as the following:
a. A diagnosis of RA using the American College
of Rheumatology (ACR) criteria for RA.
b. Swollen joint count (SJC) = 4 (66 joint count)
and tender joint count (TJC) = 4 (68 joint count)
at screening and baseline
c. C-reactive protein (CRP) = 0.6 mg/dL using a
high-sensitivity assay or erythrocyte
sedimentation rate (ESR) = 28 mm/hour
d. Positive rheumatoid factor or positive
anti-cyclic citrullinated peptide (CCP) antibody,
or both
5. Inadequate clinical response to MTX taken at a dose of
7.5-25 mg/week for at least 12 weeks, with the last 4 weeks
prior to baseline at a stable dose
6. The patient must be willing to receive oral folic acid or
equivalent.
Previous and current treatments (beyond MTX) may include the
following:
7. If the patient is receiving current treatment with
corticosteroids, the dose must not exceed 10 mg/day of
prednisolone or equivalent, and, during the 4 weeks prior to
baseline, it must be at a stable dose and remain stable for the
duration of the study.
8. If the patient is receiving current treatment with NSAIDs,
the patient must be on a stable dose for the 4 weeks prior to
baseline and remain stable for the duration of the study.
9. May have experienced an inadequate response to previous or
current treatment with other DMARDs and biologics such as
etanercept, infliximab, adalimumab, or abatacept because of
toxicity or inadequate efficacy.
10. For patients of reproductive potential (males and females), a
reliable means of contraception must be used for
the duration of the study (e.g., hormonal contraceptive,
intrauterine device, physical barrier) according to local
guidelines.
11. Female patients of childbearing age must have a negative
urine pregnancy test.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion criteria related to RA:
1. Rheumatic autoimmune disease other than RA, or significant
systemic involvement secondary to RA (including, but not
limited to, vasculitis, pulmonary fibrosis, or Felty’s
syndrome). Patients with secondary Sjögren’s syndrome or
secondary limited cutaneous vasculitis with RA are eligible.
2. Functional Class IV as defined by the ACR Classification of
Functional Status in RA.
3. History of, or current, inflammatory joint disease other than
RA (e.g. gout, reactive arthritis, psoriatic arthritis,
seronegative spondyloarthropathy, Lyme disease) or other
systemic autoimmune disorder (e.g. systemic lupus
erythematosus, inflammatory bowel disease, scleroderma,
inflammatory myopathy, mixed connective tissue disease, or
other overlap syndrome)
Exclusion criteria related to general health:
4. Any surgical procedure (except for minor surgeries requiring local or no anaesthesua and without any complications or sequaelae), including bone or joint
surgery/synovectomy (including joint fusion or replacement)
within 12 weeks prior to or planned within 48 weeks after
baseline.
5. Sepsis in a prosthetic joint within the last 48 weeks or
indefinitely if the prosthesis concerned remains in situ
6. Lack of peripheral venous access
7. Pregnancy or lactation
8. Known significant cardiac disease (New York Heart
Association [NYHA] Class III and IV).
9. Known severe chronic obstructive pulmonary disease
(COPD) (forced expiratory volume in 1 second [FEV1]
< 50% predicted or functional dyspnea Grade= 3 on
the Medical Research Council [MRC] Dyspnea Scale).
10. Evidence of significant uncontrolled concomitant diseases
11. Any neurological (congenital or acquired), psychiatric,
vascular, or systemic disorder that could affect any of the
efficacy assessments; in particular, joint pain and swelling
12. Uncontrolled disease states where flares are commonly
treated with oral or parenteral corticosteroids
13. History of, or currently active, primary or secondary
immunodeficiency including known history of HIV infection
14. Known active infection of any kind (excluding fungal
infection of nail beds) or any major episode of infection
requiring hospitalization or treatment with intravenous (IV)
anti-infectives within 4 weeks prior to baseline or oral
anti-infectives within 2 weeks prior to baseline
15. History of deep space/tissue infection (e.g., fasciitis, abscess,
osteomyelitis, or septic arthritis of a native joint) within
48 weeks of baseline
16. Evidence of chronic active hepatitis B or C
17. Evidence of active tuberculosis. Patients receiving
chemoprophylaxis for latent tuberculosis infection are
eligible for the study
18. History o

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Intervention(s)

Product Name: ocrelizumab
Product Code: RO 496-4913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
Current Sponsor code: RO 496-4913
Other descriptive name: RhuMAb 2H7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: Primary Objectives
The primary objective of this study is to determine the efficacy
and safety of 400 mg ocrelizumab, given as a single infusion,
versus placebo, in combination with MTX, to reduce the signs and
symptoms of RA at 24 weeks in patients with active RA who
currently have an inadequate response to MTX therapy.

Secondary Objective: Secondary Objectives
Secondary objectives for this study are as follows:
• To investigate and compare the pharmacokinetics and
pharmacodynamics of a single and a dual infusion of
ocrelizumab in this patient population
• To assess the effect of a single infusion of ocrelizumab versus
placebo on physical function in this patient population
• To compare the safety and efficacy of single versus dual
infusion at 24 and 48 weeks

Primary end point(s): The primary endpoint for this study is the proportion of patients with ACR20 responses at 24 weeks.

Secondary ID(s)

2007-005759-41-FR

WA20496

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 03/06/2016
• Date Completed: 26/10/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-005759-41/results