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    Summary
    EudraCT Number:2006-004834-33
    Sponsor's Protocol Code Number:ROB 803-09-002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-06
    Trial 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2006-004834-33
    A.3Full title of the trial
    A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis
    A.3.2Name or abbreviated title of the trial where available
    Robust
    A.4.1Sponsor's protocol code numberROB 803-09-002
    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 SponsorOxyPharma AB
    B.1.3.4CountrySweden
    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.4.2Country
    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 nameRob 803
    D.3.2Product code Rob 803 6.25mg capsule
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRob 803
    D.3.9.3Other descriptive name9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 No
    D.IMP: 2
    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 nameRob 803
    D.3.2Product code Rob 803 12.5mg capsule
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRob 803
    D.3.9.3Other descriptive name9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 No
    D.IMP: 3
    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 nameRob 803
    D.3.2Product code Rob 803 15mg capsule
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRob 803
    D.3.9.3Other descriptive name9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 No
    D.IMP: 4
    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 nameRob 803
    D.3.2Product code Rob 803 25mg capsule
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRob 803
    D.3.9.3Other descriptive name9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 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 placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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
    •To evaluate the efficacy of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in patients with moderate or severe active RA. Efficacy will be evaluated by ACR20 (66 joints count) after 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    •Evaluate the safety of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in patients with moderate or severe active Rheumatoid Arthritis (RA).
    •Evaluate additional efficacy parameters of Rob 803 after 4,8 and 12 weeks of treatment
    •Evaluate patient functional disability status (as measured by Modified Health Assessment Questionnaire: mHAQ)
    •Evaluate correlation between plasma concentration and effect at week 12.
    •Evaluate the pharmacokinetics of Rob 803 when administered orally in combination with a stable dose of methotrexate in a subgroup of 40 patients with moderate or severe active RA.
    •Evaluate the pharmacodynamic effect of Rob 803 administered orally in combination with a stable dose of methotrexate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥ 18 years old
    2. Diagnosed with RA based on the ARA 1987 revised criteria
    at least 16 weeks prior to study enrolment, Day 0 (Appendix B)
    3. Have an ACR global functional status class of 1 to 3
    (Appendix C)
    4. Have active disease, defined as the presence of 6 swollen
    joints and 6 tender joints in a 44 joint examination
    5. Have a CRP level at screening of ≥ 1.0mg/dL
    6. Have been taking oral or parenteral methotrexate (15 mg
    weekly or above), have been using methotrexate for at least
    16 weeks (up to Day 0 of study), and have been on a stable dose
    for at least 8 weeks, up to Day 0. (Subjects using 10 to 15 mg
    methotrexate may be considered for inclusion if an unacceptable
    toxicity was recorded when higher doses were used.)
    7. Stable optional RA medication:
    - Folic acid supplementation if already in use
    - Nonsteroidal anti-inflammatory drugs (NSAIDs)
    including cyclooxengase-2 (Cox-2) inhibitors – doses
    must be stable for 4 weeks prior to dosing with study
    drug and consistent with labelling recommendations
    - Acetylsalicylic acid is allowed in low doses as
    cardiovascular prophylaxis
    - Oral glucocorticoids, daily doses of up to 10 mg (incl.) of
    prednisolone or equivalent for 4 weeks prior to study
    enrolment (Day 0)
    - Painkillers (acetaminophen, Tramadol and similar, alone
    or in combinations) usage as per routine instructions will
    be allowed, except for 24 hours before rheumatology
    evaluations
    8. Are using adequate forms of birth control - defined as 2
    methods of birth control (eg, contraceptive pill and single-barrier
    methods). Birth control is not necessary in subjects who have
    been postmenopausal for > 1 year or who are surgically sterile
    (including hysterectomy)
    9. Subjects must be able to give informed consent after reading
    and understanding the subject information sheet, are willing to
    comply with all study procedures including completing all
    questionnaires.
    E.4Principal exclusion criteria
    1. Arthritis onset prior to 16 years old
    2. Any of the following infections:
    - Known or acute infection that may affect CRP levels
    - Active tuberculosis
    - Known chronic infection with human immunodeficiency
    virus (HIV), hepatitis C virus (HCV) or hepatitis B virus
    (HBV) including positive serology
    3. Ongoing systemic inflammatory condition which may
    interfere with the results of clinical or laboratory tests planned in
    the study (eg, systemic lupus erythematosus or any other systemic
    rheumatic disease other than RA)
    4. Any clinically significant concurrent medical condition
    resulting in the following abnormal laboratory values:
    - Hepatic
    • aspartate aminotransferase (AST) ≥ 2× the upper
    limit of normal (ULN)
    • alanine aminotransferase (ALT) ≥ 2× ULN
    • Alkaline phosphatase ≥ 2.5 × ULN
    • Total bilirubin > ULN
    - Renal
    • Serum creatinine > 1.5 × ULN
    • Urea > 1.5 × ULN
    • Significant proteinuria (2+ on urinary dipstick test)
    - Haematology­­
    • Haemoglobin < 9 g/dL
    • Leukocytes < 3.5 × 10exp6/dL
    • Absolute neutrophil count (ANC) < 1.5 × 10exp9/L
    • Platelets < 100 × 10exp6/L
    5. Present or previous malignancies, except cured squamous or
    basal skin cell carcinoma
    6. Have uncontrolled diabetes mellitus
    7. Have any medical condition, which in the judgment of the
    Investigator, will put the subject at an unacceptable risk by
    participating in the study
    8. Require one or several of the following medications:
    - Narcotics (except for Tramadol) or any drug for
    treatment of RA other than NSAIDs, Cox-2 inhibitors,
    acetaminophen/paracetamol for pain and arthritis control,
    or aspirin (except for cardiovascular prophylaxis)
    - Current or previous use of biological anti-inflammatory or immunemodulatory
    therapy for treatment of RA (e.g., anti-IL-1
    and anti-B-cell treatment)
    - Current or previous use of DMARDs (e.g.
    sulphasalazine, antimalarials, etc.), except methotrexate,
    within 4 months prior to study enrolment (Day 0)
    - Anti-tumour necrosis factor [anti-TNF] 2 months prior to
    study enrolment (Day 0)
    - Intra-articular, intramuscular, or intravenous
    glucocorticoids within 4 weeks prior to study enrolment
    (Day 0)
    9. Participation in an investigational study within the last 30
    days or expects to be treated with an investigational product
    during this study period.
    10. Current or recent history (within 12 months of screening) of
    drug or substance abuse, including alcohol
    11. Females who are pregnant or nursing
    12. Have any clinically significant abnormality on physical
    examination, laboratory testing, vital signs, or 12-lead ECG
    suggestive of a significant unstable medical condition
    13. Have any other condition that in the opinion of the
    Investigator, could interfere with the subject’s study participation.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    ACR 20 improvement measured after 12 weeks; defined as ≥ 20% improvement in tender and swollen joints count and ≥ 20% improvement in at least 3 of the following:
    - Subject Disability assessment
    - Physician Global assessment
    - Subject Global assessment
    - Subject pain assessment
    - An acute Phase Reactant (C-reactive protein).

    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 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 No
    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 years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 224
    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 Decision2008-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-06
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