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    Summary
    EudraCT Number:2010-018485-24
    Sponsor's Protocol Code Number:979
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-28
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2010-018485-24
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To investigate the efficacy and safety of SC BT061 in patients with active
    rheumatoid arthritis
    A.3.2Name or abbreviated title of the trial where available
    BT061 plus MTX in RA
    A.4.1Sponsor's protocol code number979
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiotest AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiotest AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiotest AG
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLandsteinerstr. 5
    B.5.3.2Town/ cityDreieich
    B.5.3.3Post code63303
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 (0)6103 801 1225
    B.5.5Fax number+49 (0)6103 801 180
    B.5.6E-mail979@biotest.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBT061
    D.3.2Product code BT061
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHumanised anti-CD4 IgG1 monoclonal
    D.3.9.2Current sponsor codeBT061
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHumanised anti-CD4 IgG1 monoclonal
    D.3.9.2Current sponsor codeBT061
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    is to investigate dose-response information on efficacy
    Primary efficacy variable is ACR20 (at Week 13)
    E.2.2Secondary objectives of the trial
    Is to investigate dose-response on efficacy, tolerability, safety, and pharmacokinetics (PK).
    E.2.3Trial contains a sub-study No
    E.3Principal 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. 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 (or ≥ 10 mg 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
    E.4Principal 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-α inhibitors (e.g. abatacept, rituximab, tocilizumab, anakinra)
    3. Treatment with any TNF-α 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-α 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 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-barrier method, contraceptive patch, or female sterilization) and male subjects who are not using two independent effective contraceptive methods or who are planning a sperm donation at any time during the entire study participation or in the 3 months after the last study drug administration
    29. Patients planning to donate blood between 56 days before baseline (Visit T1) and study end (Visit F6)
    30. Participation in another clinical trial within 90 days before entering or during the study
    31. Inability or lacking motivation to adhere to the study requirements and to comply with the study schedule
    E.5 End points
    E.5.1Primary end point(s)
    ACR20
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 13 (after 12 weeks of treatment)
    E.5.2Secondary end point(s)
    to investigate dose-response on various efficacy and safety variables, tolerability and pharmacokinetiks (PK)
    E.5.2.1Timepoint(s) of evaluation of this end point
    by visits and maintenance
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Cohort Study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 176
    F.4.2.2In the whole clinical trial 176
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal standard care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-05
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