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    The EU Clinical Trials Register currently displays   38596   clinical trials with a EudraCT protocol, of which   6341   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2008-001241-26
    Sponsor's Protocol Code Number:Study 971
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2008-001241-26
    A.3Full title of the trial
    A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate
    A.4.1Sponsor's protocol code numberStudy 971
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiotest AG
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 (CD4 monoclonal antibody)
    D.3.2Product code BT971
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D. medicinal product typebiological product derived from recombinant organism
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active rheumatoid arthritis, functional class II-III.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy, safety and tolerability of BT061 mab therapy in patients receiving concomitant Methotrexate (MTX)
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female and male patients with active rheumatoid arthritis.
    2. ACR criteria for diagnosis of RA, functional class II-III.
    3. Active RA as defined by:
    • ≥ 6 swollen joints on 66 joint count.
    • ≥ 6 tender joints on 68 joint count.
    • ≥ 2 of the following: Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h, morning stiffness ≥ 45 min., C-reactive Protein (CRP) ≥ 20 mg/L.
    4. Age limitations of ≥ 18 years and ≤ 75 years.
    5. Body mass index (BMI) between 18 and 30 kg/m2 inclusive, with a body weight between 50 - 110 kg.
    6. At least one traditional DMARD inadequate response despite ≥ 3 months of treatment.
    7. Concurrent RA medications with stable doses of oral MTX for ≥ 6 months before enrollment (15 to 20 mg per week or as low as 10 mg per week for patients unable to tolerate higher doses). Dose of MTX must be kept constant during study duration (treatment period and follow-up period).
    8. Concomitant medication with oral corticosteroids is allowed if stable dose of max. 10 mg (equivalent to prednisone) per day for ≥ 4 weeks prior to Screening.
    9. Concomitant medication with NSAIDs is allowed if stable dose for ≥ 4 weeks prior to Screening.
    10. No acute or relevant abnormalities in ECG.
    11. Laboratory results:
    • Hemoglobin: ≥ 8.5 g/Dl.
    • Hematocrit: > 30%.
    • White Blood Cells (WBC): ≥ 3.5 x 109 cells/L.
    • CD4 count: > 0.4 x 109 cells/L.
    • Neutrophils: ≥ 1.5 x 109 cells/L.
    • Platelets: ≥ 150 x 109 cells/L.
    • Serum transaminases (ALAT, ASAT): ≤ 3 times the upper limit of normal.
    • Bilirubin: < 3 mg/Dl.
    • Alkaline phosphatase: ≤ 2 times the upper limit of normal.
    • Urea nitrogen: < 1.5 times the upper limit of normal.
    12. B-cell count: ≥ 75% of the lower limit of normal.
    13. Signed and dated written informed consent.
    E.4Principal exclusion criteria
    1. Pre- and concomitant treatment with DMARDs other than Methotrexate, biological product(s), and intraarticular, intramuscular, or intravenous corticosteroids during the last 4 weeks prior to study inclusion and during the entire study.
    2. Previous therapy with CD4 mab (note, that a patient who took participation in Step 1 should not be enrolled in Step 2, since this patient has already been treated with BT971).
    3. Therapy with Adalimumab or Infliximab in the last 8 weeks and therapy with Etanercept in the last 4 weeks prior to study inclusion and during the entire study.
    4. Therapy with Rituximab in the last 6 months prior to study inclusion and during the entire study.
    5. Known therapy with Abatacept.
    6. Kidney insufficiency as defined by creatinine clearance: < 60 ml/min (Cockcroft Gault equation).
    7. History of severe allergic or anaphylactic reaction to proteins of human origin (e.g., vaccination reaction).
    8. Known malignancy or history of malignancy within the previous 5 years with no evidence of recurrence.
    9. History of clinically significant major disease, i.e., severe heart/lung disease NYHA ≥ 3 (New York Heart Association: class III: patients with marked limitation of activity; comfortable only at rest), autoimmune disease.
    10. Serious local (e.g., abscess) or systematic infection (e.g., pneumonia, septicaemia) within previous 3 months.
    11. Vaccinated with live, live attenuated, and/or killed vaccines in the previous 3 months prior to the first administration of the study drug.
    12. Positive diagnosis for acute or chronic infections (i.e., HBV, HCV, HIV).
    13. History of positive diagnosis for active tuberculosis.
    14. History of or recurrent acute inflammatory joint disease other than RA.
    15. Known immune deficiency.
    16. History of lymphoproliferative disease, including lymphoma and lymphadenopathy.
    17. History of clinically significant drug or alcohol abuse.
    18. The patient, planned to be enrolled is an employee of any involved study investigator or any involved institution including the study sponsor.
    19. Joint surgery within 2 months prior to Screening.
    20. Pregnant or nursing women, or woman of childbearing potential who are not using an effective contraceptive method during the study and at least four months after the last administration of study drug (e.g., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, female sterilization, or condoms). Male patients should also maintain reliable contraceptive methods during the entire study participation and at least four months after the last study drug administration.
    21. Participation in another clinical trial within 90 days before entering the study or during the study.
    22. Inability or lacking motivation to participate in the study.

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the ACR 20 response after 8 weeks (Week 9, Visit 9, Day 57±2) of treatment with:
    1. 0.5 mg BT061 IV + MTX PO or parenteral, 2.0 mg BT061 IV + MTX PO or parenteral, or placebo IV + MTX PO or parenteral for Step 1
    2. 50 mg BT061 SC + MTX PO or Placebo SC + MTX PO for Step 2
    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 No
    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. 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 No
    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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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.1.3Elderly (>=65 years) Yes
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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 Decision2008-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
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