Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01197521
First received: September 8, 2010
Last updated: March 5, 2013
Last verified: March 2013
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Purpose
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: fostamatinib Drug: placebo, fostamatinib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | (OSKIRA-1): 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 Methotrexate |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Proportion of patients with ACR20 compared to placebo (ACR20 = American College of Rheumatology 20% response criteria) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline to week 24 in mTSS (mTSS = radiographic modified total Sharp score) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients with ACR20, ACR50, ACR70, ACR-N compared to placebo (ACR50 = American College of Rheumatology 50% response criteria, ACR70 = American College of Rheumatology 70% response criteria, [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Proportion of patients with DAS28 and DAS28 EULAR response criteria compared to baseline (DAS28 = Disease Activity Score based on a 28 joint count; EULAR = European League Against Rheumatism) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Health Assessment Questionnaire - Disability Index (HAQ-DI). [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 922 |
| Study Start Date: | September 2010 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dosing Regimen A
Oral Treatment
|
Drug: fostamatinib
fostamatinib 100 mg twice daily
|
|
Experimental: Dosing Regimen B
Oral Treatment
|
Drug: fostamatinib
fostamatinib 100 mg twice daily/150 mg once daily
|
|
Placebo Comparator: Dosing Regimen C
Oral Treatment
|
Drug: placebo, fostamatinib
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily
|
Detailed Description:
Sub-study:
Full title: Optional Genetic Research
Date: 18 June 2010
Version: 1
Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Active rheumatoid arthritis (RA) diagnosed after the age of 16
- Currently taking methotrexate
- 6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
- At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)
Exclusion Criteria:
- Females who are pregnant or breast feeding
- Poorly controlled hypertension
- Liver disease or significant liver function test abnormalities
- Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
- Recent or significant cardiovascular disease
- Significant active or recent infection including tuberculosis
- Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
- Severe renal impairment
- Neutropenia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197521
Show 127 Study Locations
Show 127 Study LocationsSponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Chris O'Brien, MD PhD | AstraZeneca |
More Information
Additional Information:
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01197521 History of Changes |
| Other Study ID Numbers: | D4300C00001, 2010-020743-12 |
| Study First Received: | September 8, 2010 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Rheumatoid Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013