Clinical trial NCT01955733: Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis
Official title: Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-10-07
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase
timeFrame: Week 48
Secondary outcomes:
measure: Change From Baseline in Clinical Trial 1301.1 in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 48 of Clinical Trial 1301.4
timeFrame: Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.
measure: The Percentage of Patients Meeting the ACR20 [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4
timeFrame: Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.
measure: The Percentage of Patients Who Meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Definition of Remission [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4
timeFrame: Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.
measure: The Percentage of Patients Who Meet the EULAR Response [Good Response, Moderate Response, or no Response] [Based on DAS28 Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4
timeFrame: Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1301.4.5585 Boehringer Ingelheim Investigational Site
state: Alabama
city: Glendale
country: United States
facility: 1301.4.5727 Boehringer Ingelheim Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: 1301.4.5725 Boehringer Ingelheim Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: 1301.4.5761 Boehringer Ingelheim Investigational Site
state: Arkansas
city: El Cajon
country: United States
facility: 1301.4.5765 Boehringer Ingelheim Investigational Site
state: California
city: Lakewood
country: United States
facility: 1301.4.5553 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1301.4.5527 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1301.4.5771 Boehringer Ingelheim Investigational Site
state: California
city: Santa Maria
country: United States
facility: 1301.4.5797 Boehringer Ingelheim Investigational Site
state: California
city: Upland
country: United States
facility: 1301.4.5807 Boehringer Ingelheim Investigational Site
state: California
city: Pembroke Pines
country: United States
facility: 1301.4.5809 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1301.4.5567 Boehringer Ingelheim Investigational Site
state: Florida
city: Chicago
country: United States
facility: 1301.4.5561 Boehringer Ingelheim Investigational Site
state: Illinois
city: Columbia
country: United States
facility: 1301.4.5721 Boehringer Ingelheim Investigational Site
state: Maryland
city: Cumberland
country: United States
facility: 1301.4.5811 Boehringer Ingelheim Investigational Site
state: Maryland
city: Worcester
country: United States
facility: 1301.4.5507 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: 1301.4.5715 Boehringer Ingelheim Investigational Site
state: Michigan
city: Omaha
country: United States
facility: 1301.4.5787 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Toms River
country: United States
facility: 1301.4.5525 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: 1301.4.5779 Boehringer Ingelheim Investigational Site
state: New York
city: Charlotte
country: United States
facility: 1301.4.5717 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Dayton
country: United States
facility: 1301.4.5801 Boehringer Ingelheim Investigational Site
state: Ohio
city: Memphis
country: United States
facility: 1301.4.5549 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 1301.4.5729 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Carrollton
country: United States
facility: 1301.4.5757 Boehringer Ingelheim Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: 1301.4.5789 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1301.4.5705 Boehringer Ingelheim Investigational Site
state: Texas
city: McKinney
country: United States
facility: 1301.4.5597 Boehringer Ingelheim Investigational Site
state: Texas
city: Beckley
country: United States
facility: 1301.4.5795 Boehringer Ingelheim Investigational Site
state: West Virginia
city: Kortrijk
country: Belgium
facility: 1301.4.0303 Boehringer Ingelheim Investigational Site
city: Plovdiv
country: Bulgaria
facility: 1301.4.0609 Boehringer Ingelheim Investigational Site
city: Magdeburg
country: Germany
facility: 1301.4.1705 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1301.4.1807 Boehringer Ingelheim Investigational Site
city: Sneek
country: Netherlands
facility: 1301.4.3305 Boehringer Ingelheim Investigational Site
city: Bialystok
country: Poland
facility: 1301.4.3909 Boehringer Ingelheim Investigational Site
city: Bydgoszcz
country: Poland
facility: 1301.4.3907 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1301.4.3915 Boehringer Ingelheim Investigational Site
city: Warszawa
country: Poland
facility: 1301.4.3919 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1301.4.3917 Boehringer Ingelheim Investigational Site
city: Amadora
country: Portugal
facility: 1301.4.4013 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1301.4.4007 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1301.4.4809 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1301.4.4813 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: