Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

February 25, 2014 updated by: AstraZeneca

(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1917

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba Buenos Aires, Argentina
        • Research Site
      • Ciudad Autonoma Bs As, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Quilmes, Argentina
        • Research Site
      • San Juan, Argentina
        • Research Site
    • CBA
      • Ciudad Autonoma Bs As, CBA, Argentina
        • Research Site
    • CRD
      • Cordoba, CRD, Argentina
        • Research Site
    • Caba
      • Buenos Aires, Caba, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
    • TUC
      • San Miguel de Tucuman, TUC, Argentina
        • Research Site
  • Australia
      • Cairns, Australia
        • Research Site
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Research Site
    • Queensland
      • Southport, Queensland, Australia
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Gilly, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Yvoir, Belgium
        • Research Site
  • Brazil
      • Rio de Janeiro, Brazil
        • Research Site
    • GO
      • Goiania, GO, Brazil
        • Research Site
    • PE
      • Recife, PE, Brazil
        • Research Site
    • PR
      • Curitiba, PR, Brazil
        • Research Site
    • SP
      • Sao Paulo, SP, Brazil
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Sevlievo, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Victoria, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • Bowmanville, Ontario, Canada
        • Research Site
      • Etobicoke, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • Pointe-claire, Quebec, Canada
        • Research Site
      • Quebec City, Quebec, Canada
        • Research Site
      • Rimouski, Quebec, Canada
        • Research Site
      • Trois-rivieres, Quebec, Canada
        • Research Site
  • Chile
      • Santiago, Chile
        • Research Site
    • X Region
      • Osorno, X Region, Chile
        • Research Site
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Research Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Research Site
    • Santander
      • Bucaramanga, Santander, Colombia
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Bruntal, Czech Republic
        • Research Site
      • Ceska Lipa, Czech Republic
        • Research Site
      • Ceske Budejovice, Czech Republic
        • Research Site
      • Hlucin, Czech Republic
        • Research Site
      • Hostivice, Czech Republic
        • Research Site
      • Kladno, Czech Republic
        • Research Site
      • Liberec, Czech Republic
        • Research Site
      • Ostrava, Czech Republic
        • Research Site
      • Ostrava - Trebovice, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
      • Sokolov, Czech Republic
        • Research Site
      • Terezin, Czech Republic
        • Research Site
      • Zlin, Czech Republic
        • Research Site
  • Estonia
      • Parnu, Estonia
        • Research Site
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • France
      • Orleans Cedex 1, France
        • Research Site
  • Germany
      • Erlangen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Herne, Germany
        • Research Site
      • Koln, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Muenchen, Germany
        • Research Site
    • Nordrhein Westfalen
      • Aachen, Nordrhein Westfalen, Germany
        • Research Site
    • Sachsen
      • Halle, Sachsen, Germany
        • Research Site
  • Hungary
      • Balatonfured, Hungary
        • Research Site
      • Bekescsaba, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Mako, Hungary
        • Research Site
      • Sopron, Hungary
        • Research Site
      • Szentes, Hungary
        • Research Site
      • Zalaegerszeg-pozva, Hungary
        • Research Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Research Site
      • Secunderabad, Andhra Pradesh, India
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Research Site
      • Gandhinagar, Gujarat, India
        • Research Site
      • Vadodara, Gujarat, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
      • Mangalore, Karnataka, India
        • Research Site
      • Udupi, Karnataka, India
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Research Site
      • Pune, Maharashtra, India
        • Research Site
    • Maharshtra
      • Nagpur, Maharshtra, India
        • Research Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India
        • Research Site
      • Madurai, Tamil Nadu, India
        • Research Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India
        • Research Site
  • Israel
      • Ashkelon, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
      • Kfar-saba, Israel
        • Research Site
      • Ramat-gan, Israel
        • Research Site
      • Rehovot, Israel
        • Research Site
  • Italy
    • AN
      • Jesi, AN, Italy
        • Research Site
    • UD
      • Udine, UD, Italy
        • Research Site
    • VA
      • Varese, VA, Italy
        • Research Site
  • Latvia
      • Liepaja, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site
      • Valmiera, Latvia
        • Research Site
  • Lithuania
      • Kaunas, Lithuania
        • Research Site
      • Klaipeda, Lithuania
        • Research Site
      • Siauliai, Lithuania
        • Research Site
  • Mexico
      • Chihuahua, Mexico
        • Research Site
      • San Luis Potosi, Mexico
        • Research Site
    • Baja California
      • Mexicali, Baja California, Mexico
        • Research Site
    • Coahuila
      • Saltillo, Coahuila, Mexico
        • Research Site
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico
        • Research Site
    • JAL
      • Guadalajara, JAL, Mexico
        • Research Site
    • NL
      • Monterrey, NL, Mexico
        • Research Site
    • SON
      • Obrergon, SON, Mexico
        • Research Site
  • Peru
      • Arequipa, Peru
        • Research Site
      • Lima, Peru
        • Research Site
    • Lima
      • Pueblo Libre, Lima, Peru
        • Research Site
      • San Borja, Lima, Peru
        • Research Site
      • San Isidro, Lima, Peru
        • Research Site
  • Poland
      • Bytom, Poland
        • Research Site
      • Chelm Slaski, Poland
        • Research Site
      • Grodzisk Mazowiecki, Poland
        • Research Site
      • Kalisz, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • Zyrardow, Poland
        • Research Site
  • Portugal
      • Aveiro, Portugal
        • Research Site
      • Coimbra, Portugal
        • Research Site
      • Lisboa, Portugal
        • Research Site
      • Porto, Portugal
        • Research Site
  • Romania
      • Braila, Romania
        • Research Site
    • Prahova
      • Ploiesti, Prahova, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Nizhniy Novgorod, Russian Federation
        • Research Site
      • Petrozavodsk, Russian Federation
        • Research Site
      • Ryazan, Russian Federation
        • Research Site
      • Sankt-peterburg, Russian Federation
        • Research Site
      • Voronezh, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Kragujevac, Serbia
        • Research Site
      • Niska Banja, Serbia
        • Research Site
      • Novi Sad, Serbia
        • Research Site
  • Slovakia
      • Bratislava, Slovakia
        • Research Site
      • Poprad, Slovakia
        • Research Site
      • Rimavska Sobota, Slovakia
        • Research Site
      • Ruzomberok, Slovakia
        • Research Site
      • Trnava, Slovakia
        • Research Site
      • Zilina, Slovakia
        • Research Site
  • South Africa
      • Stellenbosch, South Africa
        • Research Site
    • Cape Town
      • Panorama, Cape Town, South Africa
        • Research Site
    • E Cape
      • Port Elizabeth, E Cape, South Africa
        • Research Site
    • Gauteng
      • Kempron Park, Gauteng, South Africa
        • Research Site
      • Pretoria, Gauteng, South Africa
        • Research Site
    • Kwazulu Natal
      • Durban, Kwazulu Natal, South Africa
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
    • Extremadura
      • Merida, Extremadura, Spain
        • Research Site
  • Ukraine
      • Donetsk, Ukraine
        • Research Site
      • Ivano-frankivsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lugansk, Ukraine
        • Research Site
      • Lutsk, Ukraine
        • Research Site
      • Lviv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Simferopol, Ukraine
        • Research Site
      • Vinnytsia, Ukraine
        • Research Site
      • Vinnytsya, Ukraine
        • Research Site
      • Zaporizhzhya, Ukraine
        • Research Site
      • Zaporyzhzhya, Ukraine
        • Research Site
  • United Kingdom
      • Basingstoke, United Kingdom
        • Research Site
      • Cambridge, United Kingdom
        • Research Site
      • Christchurch, United Kingdom
        • Research Site
      • Ipswich, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Stoke on Trent, United Kingdom
        • Research Site
      • Westcliff-on-the Sea, United Kingdom
        • Research Site
      • Wirral, United Kingdom
        • Research Site
    • Berkshire
      • Bracknell, Berkshire, United Kingdom
        • Research Site
    • Cheshire
      • Warrington, Cheshire, United Kingdom
        • Research Site
    • Greater London
      • London, Greater London, United Kingdom
        • Research Site
    • Kent
      • Maidstone, Kent, United Kingdom
        • Research Site
    • Sussex
      • Eastbourne, Sussex, United Kingdom
        • Research Site
    • West Midlands
      • Solihull, West Midlands, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Anniston, Alabama, United States
        • Research Site
      • Birmingham, Alabama, United States
        • Research Site
      • Huntsville, Alabama, United States
        • Research Site
      • Tuscaloosa, Alabama, United States
        • Research Site
    • Arizona
      • Glendale, Arizona, United States
        • Research Site
      • Mesa, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
      • Scottsdale, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • Arkansas
      • Hot Springs, Arkansas, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Fountain Valley, California, United States
        • Research Site
      • Huntington Beach, California, United States
        • Research Site
      • La Jolla, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
      • Palo Alto, California, United States
        • Research Site
      • Roseville, California, United States
        • Research Site
      • Santa Maria, California, United States
        • Research Site
      • Santa Monica, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
      • Upland, California, United States
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, United States
        • Research Site
      • Danbury, Connecticut, United States
        • Research Site
      • Trumbull, Connecticut, United States
        • Research Site
    • Delaware
      • Lewes, Delaware, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Brandon, Florida, United States
        • Research Site
      • Daytona Beach, Florida, United States
        • Research Site
      • Ft. Lauderdale, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Palm Harbor, Florida, United States
        • Research Site
      • Pinellas Park, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Tavares, Florida, United States
        • Research Site
      • Venice, Florida, United States
        • Research Site
      • Zephyr Hills, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Canton, Georgia, United States
        • Research Site
      • Decatur, Georgia, United States
        • Research Site
      • Lawrenceville, Georgia, United States
        • Research Site
      • Macon, Georgia, United States
        • Research Site
      • Marietta, Georgia, United States
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
      • South Bend, Indiana, United States
        • Research Site
    • Iowa
      • Cedar Rapids, Iowa, United States
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, United States
        • Research Site
      • Elizabethtown, Kentucky, United States
        • Research Site
    • Maryland
      • Cumberland, Maryland, United States
        • Research Site
      • Frederick, Maryland, United States
        • Research Site
      • Hagerstown, Maryland, United States
        • Research Site
      • Oxon Hill, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
      • Fall River, Massachusetts, United States
        • Research Site
      • Worcester, Massachusetts, United States
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
      • Lansing, Michigan, United States
        • Research Site
      • St. Clair Shores, Michigan, United States
        • Research Site
    • Minnesota
      • Eagan, Minnesota, United States
        • Research Site
    • Mississippi
      • Flowood, Mississippi, United States
        • Research Site
    • Missouri
      • Florissant, Missouri, United States
        • Research Site
      • Richmond Heights, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • Montana
      • Kalispell, Montana, United States
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New Jersey
      • Freehold, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
      • Las Cruces, New Mexico, United States
        • Research Site
    • New York
      • Albany, New York, United States
        • Research Site
      • Brooklyn, New York, United States
        • Research Site
      • Cooperstown, New York, United States
        • Research Site
      • Olean, New York, United States
        • Research Site
      • Roslyn, New York, United States
        • Research Site
      • Smithtown, New York, United States
        • Research Site
      • Syracuse, New York, United States
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States
        • Research Site
      • Charlotte, North Carolina, United States
        • Research Site
      • Durham, North Carolina, United States
        • Research Site
      • Greensboro, North Carolina, United States
        • Research Site
      • Research Triangle Park, North Carolina, United States
        • Research Site
    • Ohio
      • Dayton, Ohio, United States
        • Research Site
      • Mayfield Village, Ohio, United States
        • Research Site
      • Perrysburg, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Lake Oswego, Oregon, United States
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • Research Site
      • Erie, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Waxford, Pennsylvania, United States
        • Research Site
      • West Reading, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
      • Greenville, South Carolina, United States
        • Research Site
      • Orangeburg, South Carolina, United States
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Research Site
    • Tennessee
      • Hixson, Tennessee, United States
        • Research Site
      • Jackson, Tennessee, United States
        • Research Site
      • Knoxville, Tennessee, United States
        • Research Site
      • Memphis, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Amarillo, Texas, United States
        • Research Site
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Katy, Texas, United States
        • Research Site
      • Lubbock, Texas, United States
        • Research Site
      • Mesquite, Texas, United States
        • Research Site
      • Nassau Bay, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Virginia
      • Chesapeake, Virginia, United States
        • Research Site
    • Washington
      • Tacoma, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
  • Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).

Exclusion Criteria:

  • Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
  • Females who are pregnant or breast feeding
  • Poorly controlled hypertension
  • Significant liver function test abnormalities or physical symptoms of hepatotoxicity
  • Significant infection
  • Gastrointestinal intolerance
  • Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: A
Oral treatment
Drug: Fostamatinib
Fostamatinib 100mg twice daily
Drug: Fostamatinib
Fostamatinib 150mg once daily
Drug: Fostamatinib
Fostamatinib 100mg once daily
EXPERIMENTAL: B
Oral treatment
Drug: Fostamatinib
Fostamatinib 100mg twice daily
Drug: Fostamatinib
Fostamatinib 150mg once daily
Drug: Fostamatinib
Fostamatinib 100mg once daily
EXPERIMENTAL: C
Oral treatment
Drug: Fostamatinib
Fostamatinib 100mg twice daily
Drug: Fostamatinib
Fostamatinib 150mg once daily
Drug: Fostamatinib
Fostamatinib 100mg once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Time Frame: Entry in extension to end of study (variable duration; maximum 109 weeks)
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Entry in extension to end of study (variable duration; maximum 109 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean DAS28-CRP Score
Time Frame: Weeks 0, 12, 24, 36 and 52
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily
Weeks 0, 12, 24, 36 and 52
Mean mTSS Score
Time Frame: Weeks 0 and 52
mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily
Weeks 0 and 52
Mean HAQ-DI Score
Time Frame: Weeks 0, 12, 24, 36 and 52
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily
Weeks 0, 12, 24, 36 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D4300C00005
  • 2010-020892-22 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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