Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: BT061
Product Code: BT061
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Current Sponsor code: BT061
Concentration unit: mg/ml millig
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this trial, patients must meet all the following criteria: 1. Written informed consent 2. Patients of both gender with active rheumatoid arthritis (RA) according to 1987 revised ACR criteria with functional class I-III 3. Disease activity at screening (a, b, c) and baseline (a, b): a.= 6 swollen joints on 66 joint count b.= 6 tender joints on 68 joint count c.= 1 out of 2 criteria: i.erythrocyte sedimentation rate (ESR) 1. Male, = 50 years: = 23 mm/H 2. Male, > 50 years: = 30 mm/H 3. Female, = 50 years: = 30 mm/H 4. Female: > 50 years: = 45 mm/H ii.CRP = 8 mg/L 4. Duration of RA = 12 months 5. Aged 18 years - 75 years (extremes included) 6. Body mass index (BMI) 18 kg/m2 - 32 kg/m2 (extremes included) 7. History of at least one traditional disease modifying anti-rheumatic drug (DMARD) with an inadequate response despite = 3 months of treatment 8. Oral or parenteral MTX treatment for = 3 months with an unchanged mode of application and stable MTX dose = 15 mg per week (or = 10 mg per week in case of MTX intolerance) and = the upper limit of the applicable Summary of Product Characteristics (SmPC) for at least 8 weeks prior to baseline 9. Patients could continue to receive = 7.5 mg daily of oral corticosteroids (prednisone or equivalent) at the same dose received prior to the study if dose was stable for = 6 weeks prior to baseline, if applicable 10. Patients could continue to receive non-steroidal antiinflammatory drugs (NSAIDs) at the same dose as received prior to the study if dose was stable for = 2 weeks prior to baseline, if applicable 11. No acute or clinically relevant abnormalities in electrocardiogram (ECG; 12-lead) at screening and baseline 12. The following blood test results must be fulfilled at screening: a.Hemoglobin = 8.5 g/dL b.Hematocrit > 30% c.White blood cells (WBC) > 3.5*10E9 cells/L d.Neutrophils = 1.5*10E9 cells/L e.CD4 > 0.4*10E9 cells/L f.B-cell count (CD19 count) > 75% of the lower limit of normal range (LLN) g.Platelets = 150*10E9 cells/L Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: 1. Treatment with traditional DMARDs apart from MTX 12 weeks prior to baseline and for DMARD leflunomide 24 weeks (except specific leflunomide wash out procedure, i. e. 11 days with colestyramine or activated charcoal plus 30 days wash-out ) prior to baseline 2. Treatment with any biologics other than TNF-a inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra) 3. Treatment with any TNF-a inhibitor within 5 elimination half-lives (HLs) prior to baseline (e.g. 5 HLs certolizumab = 10 weeks, adalimumab = 10 weeks, etanercept = 3 weeks, infliximab = 7 weeks, golimumab = 10 weeks) and during the study 4. Clinical non-response to more than one previous TNF-a inhibitor treatment exceeding adequate treatment duration 5. Serious adverse drug reaction to previous biological treat-ment 6. Intra-articular, intramuscular, or intravenous corticosteroid treatment within 4 weeks prior to baseline and during the study 7. Previous therapy with CD4 monoclonal antibody (mab) BT061 8. Serum transaminases, alanine transaminase (ALAT) and/or aspartate transaminase (ASAT) > 2.5 fold ULN at screening 9. Bilirubin > 3 mg/dL at screening 10. Alkaline phosphatase > 2 fold ULN at screening 11. Urea nitrogen > 1.5 fold ULN at screening 12. Kidney insufficiency as defined by creatinine level > 1.5 mg/dl at screening 13. History of severe allergic or anaphylactic reaction to pro-teins of human origin (e.g. vaccination reaction, biological therapy) 14. Presence or history of malignancy within the previous 5 years (except completely resected squamous or basal cell carcinoma of the skin) 15. Presence or history of clinically significant major disease (e.g. severe heart/lung disease New York Heart Associa-tion [NYHA] Class = 3, autoimmune disease [apart from rheumatoid arthritis], acute uncontrolled hyper- or hypo-thyreoidism, severe uncontrolled hypo- or hypertension) 16. Serious local (e.g. abscess) or systemic (e.g. pneumonia, septicemia) infection or recurrent chronic infections within 6 weeks prior to screening visit or during the screening period 17. Any infection requiring antibiotic therapy by any route of administration within 2 weeks prior to baseline 18. Vaccination with live vaccines in the 12 weeks prior to the first administration of study drug and during the study or vaccination with inactivated vaccines in the first 4 weeks prior to administration of the study drug and during the study 19. Positive diagnosis for acute or chronic infections (i.e. Hepatitis C Virus [HCV], Hepatitis B Virus [HBV], Human Immunodeficiency Virus [HIV]) at Screening visit or history of previous chronic infection 20. Acute or clinically symptomatic Epstein-Barr Virus (EBV) (infectious mononucleosis) or Cytomegalovirus (CMV) infection 21. History of active tuberculosis and presence of latent or active tuberculosis 22. Presence or history of recurrent acute inflammatory joint disease other than RA 23. Known immune deficiency 24. Presence or history of lymphoproliferative disease, including lymphoma and lymphadenopathy 25. Presence or history of clinically significant drug or alcohol abuse 26. Joint surgery within 2 months prior to screening 27. The patient, planned to be enrolled, is an employee of any involved study investigator or any involved institution including the study sponsor 28. Pregnant or nursing women or women of childbearing potential (unless surgically sterile) who are not using two independent effective contraceptive methods du
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is to investigate dose-response information on efficacy. Primary efficacy variable is ACR20 (at Week 13). ;Secondary Objective: Is to investigate dose-response on efficacy, tolerability, safety, and pharmacokinetics (PK).;Primary end point(s): ACR20 ;Timepoint(s) of evaluation of this end point: Week 13 (after 12 weeks of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To investigate dose-response on various efficacy and safety variables, tolerability and pharmacokinetiks (PK);Timepoint(s) of evaluation of this end point: By visits and maintenance | — |
Countries
Czech Republic, Germany, Hungary, Latvia, Spain
Contacts
Public ContactClinical Trial Information
Biotest AG
Outcome results
None listed