Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: BI 695500
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 82 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to evaluate the long-term safety of BI 695500 in adult
      patients with moderately to severely active rheumatoid arthritis (RA) who have successfully
      completed treatment in Trial 1301.1.
    

Eligibility criteria:

        Inclusion criteria:

          1. Must give written informed consent and be willing to follow this Clinical Trial
             Protocol.

          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:

          1. Patients receiving current treatment with corticosteroids must not be receiving a dose
             exceeding 10 mg/day prednisone or equivalent.

          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.