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Efficacy & Safety of an Investigational Drug + Methotrexate Compared to Methotrexate Alone in Patients with Rheumatoid Arthritis



Efficacy & Safety of an Investigational Drug + Methotrexate Compared to Methotrexate Alone in Patients with Rheumatoid Arthritis

For Condition: Rheumatoid Arthritis
Status: No longer recruiting
Sponsor(s): Sponsor Name Pending ,
Synopsis: The purpose of this study is to help researchers confirm that an investigational drug given subcutaneously (injection given under the skin), once every 4 weeks, is an effective and safe treatment for rheumatoid arthritis in patients who are already taking methotrexate. Patients will be in this study for approximately 6 months and will need to attend the doctor's clinic on up to 12 occasions during that time. They will have a 50% chance of receiving the investigational drug and a 50% chance of receiving placebo in addition to their methotrexate. Prior to entry into this study patients will need to undergo chest x-ray and ECG (heart trace). Blood and urine tests, as well as arthritis assessments will be carried out regularly throughout the study, and patients will be required to complete health questionnaires at most clinic visits.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: - Adult onset rheumatoid arthritis of at least 6 months duration - Must have received methotrexate for at least 6 months at a stable dose Exclusion Criteria: - History of chronic infection, recent serious or life-threatening infection, or any sign or symptom indicating a current infection - History of tuberculosis - Known HIV infection - Positive hepatitis B or hepatitis C test during the pretreatment period - Active malignancy or history of malignancy - Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease - Congestive heart failure requiring medical treatment - Demyelinating disease of the central nervous system - Uncontrolled diabetes - Patient is wheelchair bound or bedridden - Abnormal blood tests results prior to study entry - Prior treatment with a TNF (tumor necrosis factor ) alpha blocking agent - Receipt of any experimental, unregistered therapy or biological therapy for rheumatoid arthritis within 6 months prior to study entry
Total Enrollment: 

Location and Contact Information:

Research Center
Köln,  ,  50924
Germany
 

Research Center
Dresden,  ,  01067
Germany
 

Research Center
Ceske Budejovice,  , 
Czech Republic
 

Research Center
Coeur D Alene,  Idaho,  83814
United States
 

Research Center
Jena,  ,  07704
Germany
 

Research Center
Berlin,  ,  14163
Germany
 

Research Center
Glasgow,  ,  G4 0SF
United Kingdom
 

Research Center
Prague,  , 
Czech Republic
 

Research Center
Harrogate,  ,  HG2 7SX
United Kingdom
 

Research Center
Peterborough,  ,  PE3 9GZ
United Kingdom
 

Research Center
Oxford,  ,  OX3 7LJ
United Kingdom
 

Research Center
Duncansville,  Pennsylvania,  16635
United States
 

Research Center
Barnsley,  South Yorkshire,  S75 2EP
United Kingdom
 

Research Center
Dublin,  ,  9
Ireland
 

Research Center
LIEGE,  ,  4000
Belgium
 

Research Center
Birmingham,  ,  B18 7QH
United Kingdom
 

Research Center
Berlin,  ,  12200
Germany
 

Research Center
Liberec,  , 
Czech Republic
 

Research Center
Mechanicsburg,  Pennsylvania,  17055
United States
 

Research Center
Hamburg,  ,  22081
Germany
 

Research Center
Glasgow,  Scotland,  G4 0SF
United Kingdom
 

Research Center
Uherske Hradiste,  ,  68601
Czech Republic
 

Research Center
Manchester,  ,  M8 6RB
United Kingdom
 

Research Center
Ostrava,  ,  70800
Czech Republic
 

Research Center
Mons,  ,  7000
Belgium
 

Research Center
Birmingham,  ,  B29 6JD
United Kingdom
 

Research Center
Worcester,  Massachusetts,  01610
United States
 

Research Center
Diepenbeek,  ,  3590
Belgium
 

Research Center
Gorlitz,  ,  02826
Germany
 

Research Center
Lincoln,  Nebraska,  68506
United States
 

Research Center
Dublin,  ,  8
Ireland
 

Research Center
Dublin,  ,  4
Ireland
 

Research Center
Berlin,  ,  14059
Germany
 

Research Center
Merksem,  ,  2170
Belgium
 

Research Center
Hamburg,  ,  20249
Germany
 

Research Center
Waterford,  , 
Ireland
 

Research Center
Vienna,  ,  A-1100
Austria
 

Research Center
Leipzig,  ,  04229
Germany
 

Research Center
Cannock,  ,  WS11 2XY
United Kingdom
 

Research Center
Erie,  Pennsylvania,  16508
United States
 

Research Center
Graz,  ,  A-8036
Austria
 

Research Center
San Antonio,  Texas,  78217
United States
 

Research Center
Ratingen,  ,  40882
Germany
 

Research Center
Antwerpen,  ,  2020
Belgium
 

Research Center
London,  ,  SE5 9RS
United Kingdom
 

Research Center
Liverpool,  Wirral,  CH49 9PE
United Kingdom
 

Research Center
Colchester,  Essex,  C04 5JL
United Kingdom
 


Additional Information:
Study ID Numbers:
  870-IFL-0587-014; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048178

Other Rheumatoid Arthritis Studies:
1. Safety Study for Remicade

2. Infliximab for the Treatment of Early Rheumatoid Arthritis

3. Meditation-based stress reduction in rheumatoid arthritis

4. ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis

5. A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects with Active Rheumatoid Arthritis

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