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    Summary
    EudraCT Number:2007-006129-29
    Sponsor's Protocol Code Number:MSC-1001
    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:2009-10-26
    Trial results Removed from public view
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2007-006129-29
    A.3Full title of the trial
    A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis
    A.3.2Name or abbreviated title of the trial where available
    MOR103 Rheumatoid Arthritis PoC Study
    A.4.1Sponsor's protocol code numberMSC-1001
    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 SponsorMorphoSys 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 supportMorphoSys AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMorphoSys AG
    B.5.2Functional name of contact pointRoman Korolkiewicz
    B.5.3 Address:
    B.5.3.1Street AddressLena-Christ-Strasse 48
    B.5.3.2Town/ cityMartinsried/Planegg
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone number4989899270
    B.5.5Fax number498989927222
    B.5.6E-mailRoman.Korolkiewicz@morphosys.com
    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 nameMOR103
    D.3.2Product code MOR103
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMOR103
    D.3.9.3Other descriptive nameHuman Recombinant IgG1, lambda
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number8 to 12
    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 infusion
    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
    Rheumatoid arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    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
    Safety and tolerability of multiple doses of MOR103 in patients with active rheumatoid arthritis.
    E.2.2Secondary objectives of the trial
    1. Signs of efficacy
    2. Pharmcokinetics of multiple doses
    3. Potential immunogenicity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Outpatients > 18 years of age
    2. BMI between 19.0 and 35.0 kg/m2 (extremes included).
    3. Diagnosis of rheumatoid arthritis (RA), according to the revised criteria of the American College of Rheumatology (ACR), 1987.
    4. Active disease at screening defined as:
    - At least 3 swollen and 3 tender joints with at least 1 swollen joint involvement of the hand excluding the proximal interphalangeal (PIP) joint (using the DAS28 joint count).
    - Elevated CRP level > 5 mg/l (in RF and anti-CCP sero-negative patients) or > 2 mg/l (in RF and/or anti-CCP sero-positive patients).
    - disease activity score "DAS28" </= 5.1
    5. Functional status class I-III classified according to ACR 1991 revised criteria.
    6. Concomitant use of the following RA treatments is allowed:
    - NSAIDs (with a stable dosage for at least 2 weeks prior to randomization)
    - Oral corticosteroids (maximum of 10 mg of prednisolone or equivalent per day with a stable dosage for at least 4 weeks prior to randomization)
    - DMARDS: Concomitant DMARD treatment for at least 3 months with stable dosage for at least 4 weeks prior to randomization. Allowable treatments include:
    • Methotrexate (maximum of 25 mg/week) either oral, s.c., or i.v. Change of the administered formulation is allowed but not within 4 weeks prior to randomization.
    • Leflunomide (maximum 20 mg/day)
    • Antimalarials (hydroxychloroquine: maximum 400 mg/day, chloroquine: maximum 500 mg/day, quinacrine [mepacrine]: maximum 100 mg/day, compounded antimalarial drugs in which no individual component exceeds the maximum dose mentioned)
    • Sulfasalazine (maximum: 3 g/day)
    • A combination of any two of these DMARDs. Combination of methotrexate and leflunomide is not allowed due to liver toxicity.
    7. Male patients must be willing to use an effective contraception method during the study and for at least 2 months following the completion/discontinuation of the study.
    8. Negative purified protein derivative (PPD) tuberculin skin test reaction or a negative tuberculosis enzyme-linked immuno sorbent assay (ELISA) test, according to the local standard practices.
    9. Possibility to evaluate pulmonary status for (latent) tuberculosis or other pulmonary infections by a chest x-ray not older than 3 month prior to screening.
    10. Provide written informed consent and be able to comply with the patient’s assessment questionnaires.
    E.4Principal exclusion criteria
    1. Previous treatment with immunosuppressive agents and non-compliance with min wash-out periods
    required prior to first dosing of study drug: 1m for etanercerpt, anakinra, ciclosporin, MMF, tacrolimus; 2m for adalimumab and certolizumab and 3m for infliximab, abatacept, golimumab and tocilizumab
    2. Previous treatment with rituximab within 9m prior to first dose of study drug
    3. History of therapy with cell depleting agent(s) incl. IMPs (Campath, anti-CD3, -CD4, -CD5, -CD11a, -CD19, -CD22, -Blys/BAFF)
    4. Any therapy with human, chimeric or murine Abs (except for above) or any experimental therapy within 3m or 5 half-lives (whichever is longer) prior to screening
    5. In case patient has been discontinued from other DMARDs due to toxicity or lack of efficacy, time since last dose at least 1m and effects of that agent should have dissipated as indicated by recognized duration of effect (e.g. hydroxychloroquine, sulfasalazine), or standard wash-out procedure (cholestyramine for leflunomide)
    6. Patients who received systemic steroids, epidural steroid injections, intra-articular or systemic corticosteroid injections within 4w before screening
    7. Known allergy to murine, chimeric or human antibodies
    8. Body weight >150 kg
    9. History of anaphylaxis/severe anaphylactic reaction/shock to any drug administered parentarally & suspected allergies to protein based therapeutics. In all other cases, subjects should be pre-treated with anti-histamines and H-1 receptor inhibitors
    10. Pregnant/breast-feeding women & pre-menopausal women not receiving methotrexate or leflunomide a/o not willing to use at least 2 methods of effective contraception during and for a specific period after studyparticipation
    11. Any findings indicative of tuberculosis or history of tuberculosis or a positive PPD- or tuberculosis ELISA test at screening
    12. Presence or history of major chronic inflammatory autoimmune diseases
    13. Positive hepatitis B surface antigen (HBs-Ag)test, hepatitis C (anti HCV antibody) test a/o confirmed HIV infection
    14. Any type of infection requiring use of antibiotics & which does not resolve completely within 3w before sudy drug administration
    15. History of recurrent pulmonary infections , recurrent abscesses, intra-abdominal infections or chronic infections
    16. Procalcitonin serum level >0.5 ng/ml at screening
    17. IgG level below lower limit of reference range at screening
    18. History of reactivation of Epstein Barr (EB) viral infection or >1,000 EBV genome equivalent/10E6 cells in peripheral blood mononuclear cell preparations
    19. History of malignancy with exception of basal cell/squamous cell carcinoma of skin/carcinoma of cervix
    successfully treated within the last 3y
    20.Significant cardiac disease on ECG
    21. History of severe pulmonary disease
    22. WBC <3.0x10E9/l, neutrophils <1.5x10E9/l, haemoglobin <10.0 g/dl, hematocrit <30%, platelets
    <100x10E9/l or absolute lymphocyte count </=0.5x10E9/l at screening
    23. Any signs of excretory hepatic (tot bilirubin >/= 1.5xULN) or renal insufficiency (creatinine clr/EGFR
    <50ml/min) at screening.
    24. Abnormal AST or ALT levels, i.e., >2x upper limit of reference range at screening
    25. Live vaccines within 8w of study drug administration
    26. Presence of contra-indications to MRI or contrast agents
    27. Any condition/laboratory findings/medical history/pre-study assessments, that in the opinion of the
    investigator constitute a risk or a contra-indication for the patient's participation in the study or that could
    interfere with study objectives, conduct or evaluation
    28. Participation in any interventional clinical trial with an IMP within 6m before start of study (or within 5 halflives of the IMP before study D1, whichever is longer)
    29. Any neurological, psychiatric, vascular or systemic disorder which could affect any of the efficacy
    assessments
    30. Active alcohol/drug abuse or history of within 24w before baseline
    31. History of deep space tissue infection within 48w of baseline
    32. Uncontrolled disease states where flares are treated with oral or parenteral corticosteroids
    For full list please refer to protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of MOR103 as assessed by the safety measures.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At end of each cohort and at the end of study
    E.5.2Secondary end point(s)
    1. Change in the DAS28 score from baseline to Days 29 and 57
    2. Proportion of patients achieving ACR20, ACR50, and ACR70 response on Day 29 and Day 57.
    3. EULAR28 responder index on Day 29 and Day 57 (compared to baseline).
    5. Change in individual components of the ACR core set of measures from baseline to Day 29 and Day 57.
    5. Change from screening to Day 29 and Day 57 of the joint scoring on MRI according to the Rheumatoid Arthritis MRI Scoring system (RAMRIS) for synovitis and bone edema.
    6. Immunogenicity of MOR103 (anti-MOR103 antibodies)
    7. Pharmacokinetics (PK) endpoint: MOR103 serum concentrations and PK parameters (trough levels after each dose, exposure and terminal elimination after the last dose, accumulation and dose proportionality based on estimated AUCtau)
    8. Health Assessment Questionnaire (HAQ), SF36, FACIT-F questionaires
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of study
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 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.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Ukraine
    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 visit of last subject undergoing the trial
    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.1.1.1.1Number of subjects for this age range: 0
    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: 89
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 89
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 89
    F.4.2.2In the whole clinical trial 89
    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)
    No specific plans for treatment of care are planned. The treating physician will decide upon adequate treatment of 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 Decision2010-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-14
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