Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01682512
First received: August 10, 2012
Last updated: June 21, 2016
Last verified: June 2016
  Purpose
The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.

Condition Intervention Phase
Arthritis, Rheumatoid
Drug: BI 695500
Drug: rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from Baseline in DAS28-ESR (Disease Activity Score 28-erythrocyte sedimentation rate) [ Time Frame: WEEK 24 ] [ Designated as safety issue: No ]
  • PK (Part I only): AUC0-inf pred (area under the plasma concentration versus time curve from time zero to infinity, over both dosages [ Time Frame: WEEK 16 ] [ Designated as safety issue: No ]
  • PK (Part I only): AUC0-336 (area under the plasma concentration versus time curve from time zero to 336 hours) [ Time Frame: WEEK 16 ] [ Designated as safety issue: No ]
  • PK (Part I only): observed Cmax (maximum plasma concentration, determined after the second drug infusion) [ Time Frame: WEEK 16 ] [ Designated as safety issue: No ]
  • PK (Part I only): AUC0-tz (area under the plasma concentration versus time curve from time zero to the last measurable concentration, (determined over both dosages) [ Time Frame: WEEK 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK (Part I only): AUC0-inf, ppk, determined over both dosages [ Time Frame: WEEK 16 ] [ Designated as safety issue: No ]
  • The proportion of patients meeting the ACR20 (American College of Rheumatology 20% response criteria) [ Time Frame: WEEK 24 ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: September 2012
Estimated Study Completion Date: November 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part I BI 695500 group
BI 695500, Two infusions separated by 2 weeks, Intravenous infusion
Drug: BI 695500
Active Comparator: Part I rituximab group 1
rituximab, Two infusions separated by 2 weeks, Intravenous infusion
Drug: rituximab
Active Comparator: Part I rituximab group 2
rituximab, Two infusions separated by 2 weeks, Intravenous infusion
Drug: rituximab
Experimental: Part II BI 695500 group
BI 695500, Two infusions separated by 2 weeks, Intravenous infusion
Drug: BI 695500
Active Comparator: Part II rituximab group
rituximab, Two infusions separated by 2 weeks, Intravenous infusion
Drug: rituximab

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Must give written informed consent and be willing to follow the protocol.
  2. Male or female participants, between 18 and 80 years of age, who have a diagnosis of moderately to severely active RA for at least 6 months as defined by at least six swollen joints (66 joint count) and at least eight tender joints (68 joint count) at Screening and Baseline (Day 1), and either an erythrocyte sedimentation rate (ESR) of > 28 mm/hour OR a CRP level > 1.0 mg/dL (normal: < 0.4 mg/dL) at Screening. Patients must have had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor.
  3. Positive for RF and/or anti-CCP antibodies.
  4. Current treatment for RA on an outpatient basis:

    1. Must be currently receiving and tolerating oral or parenteral 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) for at least 12 weeks immediately prior to Day 1. The dose should be stable for at least 4 weeks prior to Day 1 until Week 24. After Week 24 the administration route can be changed at the investigator's discretion.
    2. Patients must be willing to receive oral folic acid (at least 5 mg/week or as per local practice) or equivalent during the entire study (mandatory co-medication for MTX treatment).
    3. Biologic agents and DMARDs (other than MTX) must be withdrawn at least 2 weeks prior to Day 1, except azathioprine and etanercept which must be withdrawn at least 4 weeks prior to Day 1; abatacept, adalimumab, anakinra, certolizumab, infliximab, and golimumab at least 8 weeks prior to Day 1; tocilizumab at least 10 weeks prior to Day 1.
    4. Leflunomide must be withdrawn at least 8 weeks prior to Day 1 or a minimum of 2 weeks prior to Day 1 if after 11 days of standard cholestyramine washout.
    5. 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.
    6. Intra-articular and parenteral corticosteroids are not permitted within 6 weeks prior to Baseline Day 1 or throughout the trial, with the exception of IV administration of 100 mg methylprednisolone 30 to 60 minutes prior to each infusion as this is part of the trial procedures.
    7. Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable for at least 2 weeks prior to Day 1.
    8. 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.
  5. For participants of reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, intrauterine device, physical barrier) has to be used throughout trial participation. Females of child-bearing potential must also agree to use an acceptable method of contraception for 12 months following completion or discontinuation from the trial.

Exclusion criteria:

  1. ACR functional Class IV or wheelchair/bed bound.
  2. Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus infection.
  3. History of positive purified protein derivative test (positive tuberculosis [TB] test) without treatment for TB infection or chemoprophylaxis for TB exposure.
  4. Positive HIV or TB at screening.
  5. Known coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (New York Heart Association classes III or IV), or interstitial lung disease observed on chest X-ray.
  6. History of IgE-mediated or non-IgE-mediated hypersensitivity or known anaphylaxis to mouse proteins or a history of hypersensitivity to antibody therapy.
  7. History of cancer including solid tumors, hematologic malignancies, and carcinoma in situ (except participants with previous resected and cured basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ Grade I cervical cancer within 5 years prior to the Screening Visit).
  8. History of pancreatitis or current peptic ulcer disease.
  9. Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit.
  10. Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
  11. Pregnancy or breast feeding.
  12. History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, pulmonary fibrosis, or Feltys syndrome, scleroderma, inflammatory myopathy, mixed connective tissue disease, or any overlap syndrome).
  13. Diagnosis of juvenile idiopathic arthritis, also known as juvenile RA, and/or RA before age 16.
  14. Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to the Screening Visit or planned within 24 weeks of the Screening Visit.
  15. Lack of peripheral venous access.
  16. Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders which, in the investigator's opinion, would preclude patient participation.
  17. Known concurrent viral hepatitis or known positivity to HBe-ag, HBV DNA, HBV DNA polymerase, HCVRNA, anti HCV antibodies.
  18. Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit.
  19. History of deep space/tissue infection (e.g., fasciitis, abscess, osteomyelitis) within 52 weeks of the Screening Visit.
  20. History of serious infection or opportunistic infection in the last 2 years.
  21. Any neurological (congenital or acquired), vascular or systemic disorder that might affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinson's disease, cerebral palsy, diabetic neuropathy).
  22. Currently active alcohol or drug abuse or history of alcohol or drug abuse (as determined by the investigator) within 52 weeks of the Screening Visit.
  23. Treatment with IV Gamma Globulin or the Prosorba® Column within 6 months of the Screening Visit.
  24. Treatment with IV or intramuscular corticosteroids.
  25. Previous treatment with a B cell modulating or cell depleting therapy.
  26. Intolerance or contraindications to IV glucocorticoids.
  27. AST or ALT > 3 times ULN.
  28. Hemoglobin < 8.0 g/dL.
  29. Levels of IgG < 5.0 g/L.
  30. Absolute neutrophil count < 1500/µL.
  31. Platelet count < 75000/µL.
  32. Participation in any previous clinical trial within 12 weeks of Screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682512

  Hide Study Locations
Locations
United States, Alabama
1301.1.5565 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1301.1.5585 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arizona
1301.1.5727 Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States
1301.1.5515 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
1301.1.5709 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
1301.1.5725 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, Arkansas
1301.1.5761 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
United States, California
1301.1.5759 Boehringer Ingelheim Investigational Site
Covina, California, United States
1301.1.5765 Boehringer Ingelheim Investigational Site
El Cajon, California, United States
1301.1.5541 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
1301.1.5553 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
1301.1.5527 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1301.1.5775 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
1301.1.5771 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1301.1.5569 Boehringer Ingelheim Investigational Site
San Leandro, California, United States
1301.1.5797 Boehringer Ingelheim Investigational Site
Santa Maria, California, United States
1301.1.5773 Boehringer Ingelheim Investigational Site
Thousand Oaks, California, United States
1301.1.5807 Boehringer Ingelheim Investigational Site
Upland, California, United States
United States, Connecticut
1301.1.5711 Boehringer Ingelheim Investigational Site
Bridgeport, Connecticut, United States
United States, Florida
1301.1.5763 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
1301.1.5713 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1301.1.5577 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1301.1.5809 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
1301.1.5567 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1301.1.5743 Boehringer Ingelheim Investigational Site
Venice, Florida, United States
United States, Georgia
1301.1.5737 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
United States, Idaho
1301.1.5591 Boehringer Ingelheim Investigational Site
Coeur D'Alene, Idaho, United States
1301.1.5749 Boehringer Ingelheim Investigational Site
Idaho Falls, Idaho, United States
United States, Illinois
1301.1.5561 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Kansas
1301.1.5805 Boehringer Ingelheim Investigational Site
Overland Park, Kansas, United States
United States, Maryland
1301.1.5721 Boehringer Ingelheim Investigational Site
Columbia, Maryland, United States
1301.1.5811 Boehringer Ingelheim Investigational Site
Cumberland, Maryland, United States
1301.1.5769 Boehringer Ingelheim Investigational Site
Wheaton, Maryland, United States
United States, Massachusetts
1301.1.5507 Boehringer Ingelheim Investigational Site
Worcester, Massachusetts, United States
United States, Michigan
1301.1.5715 Boehringer Ingelheim Investigational Site
Grand Rapids, Michigan, United States
United States, Missouri
1301.1.5767 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, Nebraska
1301.1.5787 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, New Jersey
1301.1.5537 Boehringer Ingelheim Investigational Site
Clifton, New Jersey, United States
1301.1.5525 Boehringer Ingelheim Investigational Site
Toms River, New Jersey, United States
United States, New Mexico
1301.1.5785 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
United States, New York
1301.1.5779 Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
United States, North Carolina
1301.1.5717 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1301.1.5503 Boehringer Ingelheim Investigational Site
Greensboro, North Carolina, United States
United States, Ohio
1301.1.5801 Boehringer Ingelheim Investigational Site
Dayton, Ohio, United States
United States, Oklahoma
1301.1.5545 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
1301.1.5557 Boehringer Ingelheim Investigational Site
Duncansville, Pennsylvania, United States
United States, Tennessee
1301.1.5549 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
1301.1.5729 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
United States, Texas
1301.1.5757 Boehringer Ingelheim Investigational Site
Carrollton, Texas, United States
1301.1.5789 Boehringer Ingelheim Investigational Site
Corpus Christi, Texas, United States
1301.1.5705 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1301.1.5597 Boehringer Ingelheim Investigational Site
McKinney, Texas, United States
1301.1.5799 Boehringer Ingelheim Investigational Site
Webster, Texas, United States
United States, Virginia
1301.1.5783 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
United States, Washington
1301.1.5803 Boehringer Ingelheim Investigational Site
Seattle, Washington, United States
1301.1.5531 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
United States, West Virginia
1301.1.5795 Boehringer Ingelheim Investigational Site
Beckley, West Virginia, United States
1301.1.5753 Boehringer Ingelheim Investigational Site
Clarksburg, West Virginia, United States
Argentina
1301.1.0101 Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
1301.1.0115 Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
1301.1.0109 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1301.1.0121 Boehringer Ingelheim Investigational Site
Ciudad Autonoma Buenos Aires, Argentina
1301.1.0123 Boehringer Ingelheim Investigational Site
Ciudad Autonoma Buenos Aires, Argentina
1301.1.0125 Boehringer Ingelheim Investigational Site
Ciudad Autonoma Buenos Aires, Argentina
1301.1.0131 Boehringer Ingelheim Investigational Site
Rosario, Argentina
1301.1.0145 Boehringer Ingelheim Investigational Site
Rosario, Argentina
1301.1.0105 Boehringer Ingelheim Investigational Site
San Miguel de Tucuman, Argentina
1301.1.0111 Boehringer Ingelheim Investigational Site
San Miguel de Tucuman, Argentina
Belgium
1301.1.0303 Boehringer Ingelheim Investigational Site
Kortrijk, Belgium
Brazil
1301.1.0515 Boehringer Ingelheim Investigational Site
Belo Horizonte, Brazil
1301.1.0505 Boehringer Ingelheim Investigational Site
Cuiaba, Brazil
1301.1.0503 Boehringer Ingelheim Investigational Site
Curitiba, Brazil
1301.1.0531 Boehringer Ingelheim Investigational Site
Curitiba, Brazil
1301.1.0517 Boehringer Ingelheim Investigational Site
Goiania, Brazil
1301.1.0527 Boehringer Ingelheim Investigational Site
Juiz de Fora, Brazil
1301.1.0519 Boehringer Ingelheim Investigational Site
Passo Fundo, Brazil
1301.1.0533 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1301.1.0501 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1301.1.0523 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1301.1.0529 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1301.1.0513 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1301.1.0525 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1301.1.0511 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Bulgaria
1301.1.0605 Boehringer Ingelheim Investigational Site
Plovdiv, Bulgaria
1301.1.0609 Boehringer Ingelheim Investigational Site
Plovdiv, Bulgaria
1301.1.0603 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
1301.1.0613 Boehringer Ingelheim Investigational Site
Stara Zagora, Bulgaria
Canada, Ontario
1301.1.0703 Boehringer Ingelheim Investigational Site
Burlington, Ontario, Canada
Chile
1301.1.0807 Boehringer Ingelheim Investigational Site
Santiago, Chile
1301.1.0801 Boehringer Ingelheim Investigational Site
Santiago, Chile
1301.1.0803 Boehringer Ingelheim Investigational Site
Santiago, Chile
Germany
1301.1.1715 Boehringer Ingelheim Investigational Site
Berlin, Germany
1301.1.1701 Boehringer Ingelheim Investigational Site
Dresden, Germany
1301.1.1705 Boehringer Ingelheim Investigational Site
Magdeburg, Germany
1301.1.1713 Boehringer Ingelheim Investigational Site
Zerbst, Germany
Greece
1301.1.1807 Boehringer Ingelheim Investigational Site
Athens, Greece
1301.1.1809 Boehringer Ingelheim Investigational Site
Haidari, Greece
1301.1.1801 Boehringer Ingelheim Investigational Site
Larissa, Greece
Hungary
1301.1.2105 Boehringer Ingelheim Investigational Site
Budapest, Hungary
Ireland
1301.1.2403 Boehringer Ingelheim Investigational Site
Dublin, Ireland
Mexico
1301.1.3215 Boehringer Ingelheim Investigational Site
Chihuahua, Mexico
1301.1.3205 Boehringer Ingelheim Investigational Site
Ciudad Obregon, Mexico
1301.1.3217 Boehringer Ingelheim Investigational Site
Cuauhtemoc, Mexico
1301.1.3203 Boehringer Ingelheim Investigational Site
Merida, Mexico
1301.1.3201 Boehringer Ingelheim Investigational Site
Mexico, Mexico
1301.1.3207 Boehringer Ingelheim Investigational Site
Monterrey, Mexico
1301.1.3209 Boehringer Ingelheim Investigational Site
Saltillo, Mexico
1301.1.3213 Boehringer Ingelheim Investigational Site
Tijuana, Mexico
1301.1.3211 Boehringer Ingelheim Investigational Site
Tlanepantla, Mexico
Netherlands
1301.1.3301 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1301.1.3305 Boehringer Ingelheim Investigational Site
Sneek, Netherlands
New Zealand
1301.1.3405 Boehringer Ingelheim Investigational Site
Timaru, New Zealand
1301.1.3407 Boehringer Ingelheim Investigational Site
Wellington, New Zealand
Poland
1301.1.3909 Boehringer Ingelheim Investigational Site
Bialystok, Poland
1301.1.3907 Boehringer Ingelheim Investigational Site
Bydgoszcz, Poland
1301.1.3901 Boehringer Ingelheim Investigational Site
Elblag, Poland
1301.1.3915 Boehringer Ingelheim Investigational Site
Krakow, Poland
1301.1.3919 Boehringer Ingelheim Investigational Site
Warszawa, Poland
1301.1.3917 Boehringer Ingelheim Investigational Site
Wroclaw, Poland
Portugal
1301.1.4005 Boehringer Ingelheim Investigational Site
Almada, Portugal
1301.1.4013 Boehringer Ingelheim Investigational Site
Amadora, Portugal
1301.1.4001 Boehringer Ingelheim Investigational Site
Aveiro, Portugal
1301.1.4007 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1301.1.4003 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1301.1.4011 Boehringer Ingelheim Investigational Site
Porto, Portugal
1301.1.4015 Boehringer Ingelheim Investigational Site
Viseu, Portugal
Serbia
1301.1.4411 Boehringer Ingelheim Investigational Site
Belgrade, Serbia
1301.1.4415 Boehringer Ingelheim Investigational Site
Sabac, Serbia
South Africa
1301.1.4701 Boehringer Ingelheim Investigational Site
Capetown, South Africa
1301.1.4705 Boehringer Ingelheim Investigational Site
Durban, South Africa
1301.1.4711 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1301.1.4707 Boehringer Ingelheim Investigational Site
Stellenbosch, South Africa
Spain
1301.1.4821 Boehringer Ingelheim Investigational Site
Aranjuez, Spain
1301.1.4805 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1301.1.4815 Boehringer Ingelheim Investigational Site
Bilbao, Spain
1301.1.4817 Boehringer Ingelheim Investigational Site
Fuenlabrada, Spain
1301.1.4803 Boehringer Ingelheim Investigational Site
La Coruña, Spain
1301.1.4819 Boehringer Ingelheim Investigational Site
Sabadell, Spain
1301.1.4807 Boehringer Ingelheim Investigational Site
Sevilla, Spain
1301.1.4809 Boehringer Ingelheim Investigational Site
Sevilla, Spain
1301.1.4813 Boehringer Ingelheim Investigational Site
Sevilla, Spain
Ukraine
1301.1.5423 Boehringer Ingelheim Investigational Site
Ivano-Frankivsk, Ukraine
1301.1.5403 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
1301.1.5411 Boehringer Ingelheim Investigational Site
Kyiv, Ukraine
1301.1.5421 Boehringer Ingelheim Investigational Site
Kyiv, Ukraine
1301.1.5417 Boehringer Ingelheim Investigational Site
Lutsk, Ukraine
1301.1.5419 Boehringer Ingelheim Investigational Site
Lviv, Ukraine
1301.1.5425 Boehringer Ingelheim Investigational Site
Poltava, Ukraine
1301.1.5405 Boehringer Ingelheim Investigational Site
Vinnytsia, Ukraine
1301.1.5407 Boehringer Ingelheim Investigational Site
Vinnytsia, Ukraine
1301.1.5415 Boehringer Ingelheim Investigational Site
Vinnytsia, Ukraine
1301.1.5401 Boehringer Ingelheim Investigational Site
Zaporizhzhia, Ukraine
United Kingdom
1301.1.5313 Boehringer Ingelheim Investigational Site
Cardiff, United Kingdom
1301.1.5307 Boehringer Ingelheim Investigational Site
London, United Kingdom
1301.1.5309 Boehringer Ingelheim Investigational Site
London, United Kingdom
1301.1.5311 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne, United Kingdom
1301.1.5305 Boehringer Ingelheim Investigational Site
Stoke on Trent, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01682512     History of Changes
Other Study ID Numbers: 1301.1  2011-002894-48 
Study First Received: August 10, 2012
Last Updated: June 21, 2016
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Germany: Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee Research Involving Human Subjects
New Zealand: Medsafe
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 21, 2016