Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis
NCT ID: NCT01955733
Last Updated: 2018-01-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
91 participants
INTERVENTIONAL
2013-05-31
2016-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BI 695500
BI 695500, Two infusions separated by 2 weeks, Intravenous infusion
BI 695500
Interventions
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BI 695500
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients, with moderately to severely active RA who have previously participated in the double-blind randomized clinical Trial 1301.1.
3. Current treatment for RA on an outpatient basis:
1. Patients must continue to receive and tolerate oral or parenteral methotrexate (MTX) therapy at a dose of 15-25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose).
2. Patients must be willing to receive oral folic acid (at least 5 mg/week or as per local practice) or folinic acid (at least 1 mg per week or as per local practice) or equivalent during the entire trial.
3. If receiving current treatment with oral corticosteroids (other than intra-articular or parenteral), the dose must not exceed 10 mg/day prednisolone or equivalent. During the 4 weeks prior to Baseline (Day 1) the dose must remain stable.
4. Intra-articular and parenteral corticosteroids are not permitted throughout the trial, with the exception of IV administration of 100 mg methylprednisolone 30 to 60 minutes prior to each infusion as part of the trial procedures.
5. Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable throughout the trial.
6. Patients may be taking oral hydroxychloroquine provided that the dose is not greater than 400 mg/day, or chloroquine provided that the dose is not greater than 250 mg/day. These doses must have been stable for a minimum of 12 weeks prior to Day 1. The hydroxychloroquine or chloroquine treatment will need to be continued at a stable dose with the same formulation until the end of the trial.
4. For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial, i.e., a combination of 2 forms of effective contraception (defined as hormonal contraception, intrauterine device, condom with spermicide, etc.). Females of childbearing potential must also agree to use an acceptable method of contraception (see above) for 12 months following completion or discontinuation from the trial medication.
Exclusion Criteria
2. Serious underlying medical conditions, which, per the investigator¿s discretion, could impair the ability of the patient to participate in the trial (including but not limited to ongoing severe infection, severe immunosuppression, severe heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
3. Pregnancy or breast feeding. For women of childbearing potential, a positive serum pregnancy test at the Screening Visit.
4. Patients who have significant cardiac disease, including but not limited to congestive heart failure of Class III or IV of the New York Heart Association (NYHA) classification; uncontrolled angina or arrhythmia; any uncontrolled or severe cardiovascular or cerebrovascular disease; or uncontrolled hypertension.
5. Treatment with IV or intramuscular corticosteroids. The only exception will be the administration of 100 mg IV methylprednisolone 30 to 60 minutes before each infusion as part of the trial procedures.
6. Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times upper limit of normal (ULN).
8. Hemoglobin \<8.0 g/dL.
9. Levels of Immunoglobulin G(IgG) \<5.0 g/L.
10. Absolute neutrophil count \<1500/µL.
11. Platelet count \<75000/µL.
18 Years
82 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1301.4.5585 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1301.4.5727 Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States
1301.4.5725 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1301.4.5761 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
1301.4.5765 Boehringer Ingelheim Investigational Site
El Cajon, California, United States
1301.4.5553 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
1301.4.5527 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1301.4.5771 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1301.4.5797 Boehringer Ingelheim Investigational Site
Santa Maria, California, United States
1301.4.5807 Boehringer Ingelheim Investigational Site
Upland, California, United States
1301.4.5809 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
1301.4.5567 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1301.4.5561 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1301.4.5721 Boehringer Ingelheim Investigational Site
Columbia, Maryland, United States
1301.4.5811 Boehringer Ingelheim Investigational Site
Cumberland, Maryland, United States
1301.4.5507 Boehringer Ingelheim Investigational Site
Worcester, Massachusetts, United States
1301.4.5715 Boehringer Ingelheim Investigational Site
Grand Rapids, Michigan, United States
1301.4.5787 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
1301.4.5525 Boehringer Ingelheim Investigational Site
Toms River, New Jersey, United States
1301.4.5779 Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
1301.4.5717 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1301.4.5801 Boehringer Ingelheim Investigational Site
Dayton, Ohio, United States
1301.4.5549 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
1301.4.5729 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
1301.4.5757 Boehringer Ingelheim Investigational Site
Carrollton, Texas, United States
1301.4.5789 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas, United States
1301.4.5705 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1301.4.5597 Boehringer Ingelheim Investigational Site
McKinney, Texas, United States
1301.4.5795 Boehringer Ingelheim Investigational Site
Beckley, West Virginia, United States
1301.4.0303 Boehringer Ingelheim Investigational Site
Kortrijk, , Belgium
1301.4.0609 Boehringer Ingelheim Investigational Site
Plovdiv, , Bulgaria
1301.4.1705 Boehringer Ingelheim Investigational Site
Magdeburg, , Germany
1301.4.1807 Boehringer Ingelheim Investigational Site
Athens, , Greece
1301.4.3305 Boehringer Ingelheim Investigational Site
Sneek, , Netherlands
1301.4.3909 Boehringer Ingelheim Investigational Site
Bialystok, , Poland
1301.4.3907 Boehringer Ingelheim Investigational Site
Bydgoszcz, , Poland
1301.4.3915 Boehringer Ingelheim Investigational Site
Krakow, , Poland
1301.4.3919 Boehringer Ingelheim Investigational Site
Warsaw, , Poland
1301.4.3917 Boehringer Ingelheim Investigational Site
Wroclaw, , Poland
1301.4.4013 Boehringer Ingelheim Investigational Site
Amadora, , Portugal
1301.4.4007 Boehringer Ingelheim Investigational Site
Lisbon, , Portugal
1301.4.4809 Boehringer Ingelheim Investigational Site
Seville, , Spain
1301.4.4813 Boehringer Ingelheim Investigational Site
Seville, , Spain
Countries
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Other Identifiers
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2013-002622-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1301.4
Identifier Type: -
Identifier Source: org_study_id
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