Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

• Register: EUCTR
• Last refreshed on: 13 May 2013
• Main ID: EUCTR2010-020744-35-LV
• Date of registration: 13/08/2010
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)
• Scientific title: A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2
• Date of first enrolment: 22/10/2010
• Target sample size: 900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020744-35
• 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

Countries of recruitment

Canada, Czech Republic, Germany, Israel, Italy, Latvia, Lithuania, Portugal, Romania, Serbia, South Africa, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Information Center
• Affiliation: Astra Zeneca AB

• Name: Information Center
• Affiliation: Astra Zeneca AB

Key inclusion & exclusion criteria

Inclusion criteria:
1.Male or female aged 18 and over
2. A diagnosis of RA after the age of 16
3. Currently taking 1 of the following traditional DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.

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 810
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion criteria:
1.Females who are pregnant/lactating
2.Any systemic inflammatory conditions(other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data
3. Poorly controlled blood pressure
4.History of liver function abnormality requiring investigation, drug induced liver injury, chronic liver disease, excessive alcohol consumption/chronic alcohol induced disease



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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Rheumatoid Arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Fostamatinib disodium
Product Code: FosD
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Fostamatinib disodium
CAS Number: 914295-16-2
Current Sponsor code: FosD
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

Primary Outcome(s)

Secondary Objective: The secondary objectives of the study assessed over the 52-week study
period are:
•To assess the efficacy of fostamatinib in the prevention of structural
joint damage, as measured by change in radiographic modified Total
Sharp Score (mTSS) and the components of mTSS at Week 24 and Week
52.
•To further assess the efficacy of fostamatinib measured by ACR20, ACR
50% response criteria (ACR50), ACR 70% response criteria (ACR70),
major clinical response, 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 evaluate the efficacy of fostamatinib as measured by Disease
Activity Score based on a 28 joint count (DAS28) and DAS28 European
League Against Rheumatism (EULAR) response criteria.
•To investigate the effects of fostamatinib on patient reported health
outcomes measures.

Primary end point(s): The primary endpoint in this study is the proportion of patients achieving ACR20 at Week 24.

Main Objective: The primary objective of this study is to evaluate the efficacy of 2 oral dosing regimens of fostamatinib (Regimen A - 100 mg twice daily (bid); Regimen B - induction with 100 mg bid for the first 4 weeks, 150 mg once daily (qd) maintenance thereafter) taken in combination with a disease-modifying anti-rheumatic drug (DMARD), compared with placebo plus a DMARD, in patients with active rheumatoid arthritis (RA).

Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome(s)

Secondary end point(s): - mTSS, radiographic erosion score (ES) and joint space narrowing
(JSN).
- ACR20, ACR50, ACR70, major clinical response, 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
- DAS28 response, DAS28 EULAR response criteria, DAS low disease
activity, DAS28 remission, clinically important change in DAS28 score.

Timepoint(s) of evaluation of this end point: Secondary timepoints are: Screening plus week 0-6, 12, 24, 28, 36 and
52.

For mTSS JSN (X-ray) timepoints 0, 12, 24 and 52

Secondary ID(s)

D4300C00002

2010-020744-35-GB

NCT01197534

Source(s) of Monetary Support

Astra Zeneca AB