Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis
Verified October 2015 by Boehringer Ingelheim
Information provided by (Responsible Party):
First received: September 30, 2013
Last updated: October 5, 2015
Last verified: October 2015
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.
Drug: BI 695500
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension Trial
Primary Outcome Measures:
- Number (proportion) of patients with drug related adverse events during the treatment phase [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The change from Baseline in Trial 1301.1 in DAS28 (erythrocyte sedimentation rate [ESR]) at Week 48 of Trial 1301.4 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
- The proportion of patients meeting the American College of Rheumatology 20% (ACR20) response criteria (based on improvement since Baseline in Trial 1301.1) at Week 48 of Trial 1301.4 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
- The proportion of patients who meet the 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 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
- The proportion 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 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2016 (Final data collection date for primary outcome measure)
Experimental: BI 695500
BI 695500, Two infusions separated by 2 weeks, Intravenous infusion
Drug: BI 695500
|Ages Eligible for Study:
||18 Years to 82 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Must give written informed consent and be willing to follow this CTP.
- Male or female patients, with moderately to severely active RA who have previously participated in the double-blind randomized clinical Trial 1301.1.
Current treatment for RA on an outpatient basis:
- 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).
- 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.
- 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 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.
- Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable throughout the trial.
- 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 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.
- Patients receiving current treatment with corticosteroids must not be receiving a dose exceeding 10 mg/day prednisone or equivalent.
- 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).
- Pregnancy or breast feeding. For women of childbearing potential, a positive serum pregnancy test at the Screening Visit.
- 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.
- 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.
- Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times upper limit of normal (ULN).
- Hemoglobin <8.0 g/dL.
- Levels of IgG <5.0 g/L.
- Absolute neutrophil count <1500/µL.
- Platelet count <75000/µL.
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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: NCT01955733
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 30, 2013
||October 5, 2015
||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
Estonia: The State Agency of Medicine
France: Agence Nationale sécurité médicament et des produits santé
Greece: National Organization of Medicines
Guatemala: Ministry of Public Health and Social Assistance
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: National Institute of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Peru: Ministry of Health
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Health and Social Development Russian Federation
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
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 08, 2015
Connective Tissue Diseases
Immune System Diseases
Physiological Effects of Drugs