A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA
- Conditions
- Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2010-018485-24-ES
- Lead Sponsor
- Biotest AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 128
To participate in this trial, patients must meet all the following criteria:
1. Written informed consent
2. Patients of both gender with active RA according to 1987 revised American
College of Rheumatology (ACR) criteria with functional class II-III
3. Disease activity at screening and baseline:
a.= 6 swollen joints on 66 joint count and
b.= 6 tender joints on 68 joint count and
c.= 1 out of the 2 criteria:
i.erythrocyte sedimentation rate (ESR)
male, = 50 years: = 23 mm/H
male, > 50 years: = 30 mm/H
female, = 50 years: = 30 mm/H
female: > 50 years: = 45 mm/H
ii.C-reactive protein (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 - 30 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 = 6 months with an unchanged mode of application and stable MTX dose = 15 mg (or = 10 mg in case of MTX intolerance) and = the upper limit of the applicable Summary of Product Charac-teristics (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 antiinflam-matory 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 electrocar-diogram (ECG; 12-lead) at screening and baseline
12. The following blood test results must be fulfilled at screen-ing:
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Treatment with traditional DMARDs apart from MTX 12 weeks prior to baseline and for DMARD leflunomide 24 weeks (except specific leflunomide wash out proce-dure, 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 prior to baseline (e.g. 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 screening 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, live attenuated, and/or killed vac-cines in the 12 weeks prior to the first administration of the study drug and during the study
19. Positive diagnosis for acute or chronic infections (i.e. He-patitis C Virus [HCV], Hepatitis B Virus [HBV], Human Im-munodeficiency 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) in-fection
21. Presence or history 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, includ-ing 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 in-cluding 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 during the study and for at least 3 months after the last administration of study drug (e.g. oral or injectable contraceptives, intrauterine devices, double
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method