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

Stopped early · Phase 3

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT01682512

Run by

Boehringer Ingelheim

People needed

294

Starts

2012-09-05

Expected to finish

2016-10-12

Last updated by the study team

2018-01-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must give written informed consent and be willing to follow the protocol.
• 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 C-reactive protein (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 tumor necrosis factor (TNF) inhibitor.
• Positive for Radio Frequency and/or anti-CCP (Anti-cyclic citrullinated peptide) antibodies.
• Current treatment for RA on an outpatient basis:
• 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.
• 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).
• Biologic agents and DMARDs (other than MTX) must be withdrawn at least 2 weeks prior to Day 1, except azathioprine and etanercept which must be withdrawn at least 4 weeks prior to Day 1; abatacept, adalimumab, anakinra, certolizumab, infliximab, and golimumab at least 8 weeks prior to Day 1; tocilizumab at least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.
• 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.
• 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.
• 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.
• Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable for at least 2 weeks prior to Day 1.
• 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.
• 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.

You may not qualify if…

• ACR functional Class IV or wheelchair/bed bound.
• Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus infection.
• History of positive purified protein derivative test (positive tuberculosis [TB] test) without treatment for TB infection or chemoprophylaxis for TB exposure.
• Positive HIV or TB at screening.
• 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.
• History of IgE-mediated (immunoglobulin E) or non-IgE-mediated hypersensitivity or known anaphylaxis to mouse proteins or a history of hypersensitivity to antibody therapy.
• 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).
• History of pancreatitis or current peptic ulcer disease.
• Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit.
• Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
• Pregnancy or breast feeding.
• 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).
• Diagnosis of juvenile idiopathic arthritis, also known as juvenile RA, and/or RA before age 16.
• 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.
• Lack of peripheral venous access.
• 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.
• Known concurrent viral hepatitis or known positivity to HBe-ag, HBV DNA, HBV DNA polymerase, HCVRNA, anti HCV antibodies.
• 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.
• History of deep space/tissue infection (e.g., fasciitis, abscess, osteomyelitis) within 52 weeks of the Screening Visit.
• History of serious infection or opportunistic infection in the last 2 years.
• 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).
• 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.
• Treatment with IV Gamma Globulin or the Prosorba® Column within 6 months of the Screening Visit.
• Treatment with IV or intramuscular corticosteroids.
• Previous treatment with a B cell modulating or cell depleting therapy.

Where it is running

• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Arizona Arthritis &amp;amp; Rheumatology Associates, P.C. — Glendale, Arizona, United States
• Arizona Arthritis and Rheumatology Research, PLLC — Mesa, Arizona, United States
• Arizona Arthritis and Rheumatology Research, PLLC — Mesa, Arizona, United States
• Arizona Arthritis and Rheumatology Research, PLLC — Phoenix, Arizona, United States
• Little Rock Diagnostic Clinic — Little Rock, Arkansas, United States
• Medvin Clinical Research — Covina, California, United States
• TriWest Research Associates, LLC — El Cajon, California, United States
• Advanced Medical Research, LLC — Lakewood, California, United States
• Premiere Clinical Research, LLC — Lakewood, California, United States
• ProHealth Partners — Long Beach, California, United States
• San Diego Arthritis Medical Clinic — San Diego, California, United States
• Arthritis Center Medical Group — Santa Maria, California, United States
• Westlake Medical Research — Thousand Oaks, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• Nascimento, Joao (Private Practice) — Bridgeport, Connecticut, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Arthritis Associates, Inc. — Orlando, Florida, United States
• Family Clinical Trials, Incorporated — Pembroke Pines, Florida, United States
• Arthritis &amp;amp; Rheumatology Associates of Palm Beach — Tampa, Florida, United States
• Lovelace Scientific Resources, Incorporated — Venice, Florida, United States
• Coeur d'Alene Arthritis Clinical Trials — Coeur d'Alene, Idaho, United States
• Institute of Arthritis Research — Idaho Falls, Idaho, United States
• Rheumatology Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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