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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 27 January 2014
Main ID:  EUCTR2010-023692-26-DE
Date of registration: 07/12/2010
Prospective Registration: Yes
Primary sponsor: AstraZeneca AB
Public title: Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared with Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)
Scientific title: (OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4
Date of first enrolment:
Target sample size: 370
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023692-26
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: yes Placebo: yes Other: no  
Phase: 
Countries of recruitment
Bulgaria Canada Czech Republic Germany Hungary Netherlands Poland Russian Federation
Slovakia South Africa Ukraine United Kingdom United States
Contacts
Name: Information Centre   
Address: 
Telephone:
Email: information.center@astrazeneca.com
Affiliation:  AstraZeneca AB
Name: Information Centre   
Address: 
Telephone:
Email: information.center@astrazeneca.com
Affiliation:  AstraZeneca AB
Key inclusion & exclusion criteria
Inclusion criteria:
1) Provision of informed consent, prior to any study-specific procedures.
2) Male or female aged 18 and over.
3) Diagnosis of RA, after the age of 16 according to the revised (1987) criteria of the American College of Rheumatology and one of the following:
-diagnosis within 5 years prior to Visit 1 and inadequate response to treatment with a maximum of 2 of the following DMARD therapies: methotrexate, leflunomide, sulfasalazine, azathioprine, cyclosporine, gold, penacillamine, minocycline, mycophenolate, cyclophosphamide, tacrolimus or doxycycline
or
-diagnosis within 5 years prior to Visit 1 and intolerance to DMARD therapy
or
-diagnosis within 2 years prior to Visit 1 and no previous use of DMARDs.
4) Active RA defined as:
- =4 swollen joints and =4 tender/painful joints (from 28 joint count)
and either:
- ESR =28 mm/h, or
- CRP =10 mg/L
5) At least 2 of the following:
-Documented history or current presence of positive rheumatoid factor (RF)
-Radiographic erosion within 12 months prior to enrolment
-Presence of serum anti-cyclic citrullinated peptide antibodies (anti CCP).

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 252
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion criteria:
1) Use of any DMARDs within 6 weeks prior to Visit 1
2) Patients who have previously received treatment with a TNF alpha antagonist (including etanercept, certolizumab, adalimumab, infliximab, golimumab) or anakinra or previous treatment with other biological agent including rituximab, abatacept and tocilizumab
3) Females who are pregnant or lactating
4) Any systemic inflammatory conditions (other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data.
5) Poorly controlled blood pressure
6) History of liver problems that have required previous investigation
7) Evidence of recent or significant CV disease, active or recent infection or evidence of tuberculosis infection


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Product Name: Fostamatinib disodium
Product Code: previously known as R935788
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib disodium
CAS Number: 914295-16-2
Other descriptive name: Fostamatinib disodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Other descriptive name: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40 / 0,8 ml-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)
Main Objective: The primary objectives of this study are:
• To evaluate the efficacy of 3 oral dosing regimens of fostamatinib disodium (FosD) compared with placebo when used as monotherapy in patients with active rheumatoid arthritis (RA) by assessment of: The signs and symptoms of RA, as measured by Disease Activity Score based on a 28 joint count (DAS28) at Week 6.
• To evaluate whether the efficacy of 3 oral dosing regimens of fostamatinib are non-inferior to that of adalimumab (Humira®) when used as monotherapy in patients with active RA by assessment of: The signs and symptoms of RA, as measured by DAS28 at Week 24.
Primary end point(s): The primary endpoints in this study are the signs and symptoms of RA, as measured by DAS28 at Week 6 and DAS28 at Week 24.
Secondary Objective: The secondary objectives of the study are:
• To further assess the efficacy of fostamatinib measured by DAS28, DAS28 response criteria, American College of Rheumatology 20% response criteria (ACR20), ACR 50% response criteria (ACR50), ACR 70% response criteria (ACR70), ACR-N and the individual components of the ACR score.
• To assess physical function status of patients after administration of fostamatinib using the Health Assessment Questionnaire - Disability Index (HAQ-DI).
• To investigate the effects of fostamatinib on health-related quality of life using the 36-item Short Form Health Survey (SF-36) questionnaire.
Timepoint(s) of evaluation of this end point: Week 6 and 24.
Secondary Outcome(s)
Secondary end point(s): Secondary outcome variables:
- DAS28 score, DAS28 response criteria, DAS low disease activity, DAS28 remission, clinically important change in DAS28 score
- ACR20, ACR50, ACR70, ACR-N, individual components of ACR (swollen joint count, tender joint count, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the HAQ-DI, C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR])
- HAQ-DI score; HAQ-DI response, individual dimensions of HAQ-DI.
Timepoint(s) of evaluation of this end point: Secondary timepoints are: Screening plus week 0 to 6, 12, 18 and 24.
Secondary ID(s)
2010-023692-26-GB
D4300C00004
NCT01264770
Source(s) of Monetary Support
AstraZeneca AB
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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