Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis

This study has been terminated.
(Study is terminated due to lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01285310
First received: November 19, 2010
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to determine whether Apremilast is safe and effective in the treatment of patients with rheumatoid arthritis, specifically in improving signs and symptoms of rheumatoid arthritis (tender and swollen joints, pain, physical function and structure) in treated patients who have had an inadequate response to Methotrexate.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Apremilast 30 mg
Drug: Apremilast 20 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study, To Compare the Efficacy and Safety of Two Doses of Apremilast (CC-10004) in Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • American College of Rheumatology criterion for at least 20% improvement [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 20% improvement (ACR20) from baseline


Secondary Outcome Measures:
  • Number of participants with AEs [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]
    Type, frequency, severity, seriousness and relationship of adverse events to apremilast

  • Number of participants prematurely discontinuing due to AEs [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]
    Number of participants who prematurely discontinue investigational product due to any adverse event

  • Frequency of clinically significant changes AEs associated with a physical examination, vital signs, electrocardiogram (ECG) and/or laboratory findings during all treatment phases [ Time Frame: Up to 108 weeks ] [ Designated as safety issue: Yes ]
    Frequency of clinical significant changes in physical examination, vital signs, electrocardiogram, and/or laboratory findings

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline in physical function using Health Assessment Questionnaire-Disability Index (HAQ-DI)

  • American College of Rheumatology criterion for at least 20% improvement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 20% improvement compared with baseline

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in physical function using Health Assessment Questionnaire-Disability Index (HAQ-DI)

  • Short Form-36 Version 2 (SF-36) physical function domain score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Medical Outcome Study Short Form-36 Version 2 (SF-36) physical function domain score

  • Clinical Disease Activity Index (CDAI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Clinical Disease Activity Index (CDAI)

  • Clinical Disease Activity Index (CDAI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve low disease activity or remission based on the Clinical Disease Activity Index (CDAI) ≤ 10

  • Disease Activity Score 28 (DAS28) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Disease Activity Score 28 (DAS28), compared with baseline

  • Individual American College of Rheumatology (ACR) criterion components [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Percentage change from baseline in the individual American College of Rheumatology criterion components, compared with baseline

  • Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an improvement of ≥ 0.22 units from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)

  • Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an improvement of at least 4 units from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)

  • European League Against Rheumatism (EULAR) response criteria [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve the European League Against Rheumatism (EULAR) response criteria

  • American College of Rheumatology (ACR) criterion for at least 50% improvement [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 50% improvement (ACR50) from baseline

  • American College of Rheumatology (ACR) criterion for at least 70% improvement [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 50% improvement (ACR70) from baseline

  • American College of Rheumatology criterion for at least 50% improvement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 50% improvement (ACR50) from baseline

  • American College of Rheumatology criterion for at least 70% improvement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 70% improvement (ACR70) from baseline

  • Short Form-36 Version 2 (SF-36) physical function domain score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Medical Outcome Study Short Form-36 Version 2 (SF-36) physical function domain score

  • Clinical Disease Activity Index (CDAI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Clinical Disease Activity Index (CDAI)

  • Clinical Disease Activity Index (CDAI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve low disease activity or remission based on the Clinical Disease Activity Index (CDAI) ≤ 10

  • Disease Activity Score 28 (DAS28) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Disease Activity Score 28 (DAS28), compared with baseline

  • Individual American College of Rheumatology (ACR) criterion components [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Percentage change from baseline in the individual American College of Rheumatology criterion components, compared with baseline

  • Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an improvement of ≥ 0.22 units from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)

  • Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an improvement of at least 4 units from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)

  • European League Against Rheumatism (EULAR) response criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve the European League Against Rheumatism (EULAR) response criteria

  • American College of Rheumatology criterion for at least 20% improvement [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 20% improvement compared with baseline

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in physical function using Health Assessment Questionnaire-Disability Index (HAQ-DI)

  • Short Form-36 Version 2 (SF-36) physical function domain score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Medical Outcome Study Short Form-36 Version 2 (SF-36) physical function domain score

  • Clinical Disease Activity Index (CDAI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Clinical Disease Activity Index (CDAI)

  • Clinical Disease Activity Index (CDAI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve low disease activity or remission based on the Clinical Disease Activity Index (CDAI) ≤ 10

  • Disease Activity Score 28 (DAS28) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Disease Activity Score 28 (DAS28), compared with baseline

  • Individual American College of Rheumatology (ACR) criterion components [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Percentage change from baseline in the individual American College of Rheumatology (ACR) criterion components, compared with baseline

  • Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an improvement of ≥ 0.22 units from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)

  • American College of Rheumatology (ACR) criterion for at least 50% improvement [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 50% improvement (ACR50) from baseline

  • American College of Rheumatology (ACR) criterion for at least 70% improvement [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 70% improvement (ACR70) from baseline

  • Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an improvement of at least 4 units from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)

  • European League Against Rheumatism (EULAR) response criteria [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of participants who achieve the European League Against Rheumatism (EULAR) response criteria

  • American College of Rheumatology (ACR) criterion for at least 20% improvement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 20% improvement (ACR20) from baseline

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change from baseline in physical function using Health Assessment Questionnaire-Disability Index (HAQ-DI)

  • Short Form-36 Version 2 (SF-36) physical function domain score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change from baseline in the Medical Outcome Study Short Form-36 Version 2 (SF-36) physical function domain score

  • Clinical Disease Activity Index (CDAI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change from baseline in the Clinical Disease Activity Index (CDAI)

  • Clinical Disease Activity Index (CDAI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of participants who achieve low disease activity or remission based on the Clinical Disease Activity Index (CDAI) ≤ 10

  • Disease Activity Score 28 (DAS28) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change from baseline in the Disease Activity Score 28 (DAS28), compared with baseline

  • Individual American College of Rheumatology (ACR) criterion components [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Percentage change from baseline in the individual American College of Rheumatology criterion components, compared with baseline

  • Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an improvement of ≥ 0.22 units from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)

  • American College of Rheumatology (ACR) criterion for at least 50% improvement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an American College of Rheumatology criterion for at least 50% improvement (ACR50) from baseline

  • American College of Rheumatology (ACR) criterion for at least 70% improvement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    : Proportion of participants who achieve an American College of Rheumatology criterion for at least 70% improvement (ACR70) from baseline

  • Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of participants who achieve an improvement of at least 4 units from baseline in the Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)

  • European League Against Rheumatism (EULAR) response criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Proportion of participants who achieve the European League Against Rheumatism (EULAR) response criteria

  • Area under the plasma concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To characterize the systemic exposure of apremilast (20 mg twice daily and 30 mg twice daily) based on the intensive pharmacokinetics at Week 12 (for example: blood draws at pre-dose and up to 8 hours post-dose): Area under the plasma concentration - time curve (AUC 0-8)

  • Peak (maximum) plasma concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To characterize the systemic exposure of apremilast (20 mg twice daily and 30 mg twice daily) based on the intensive pharmacokinetics at Week 12 (for example: blood draws at pre-dose and up to 8 hours post-dose): Peak (maximum) plasma concentration of apremilast (Cmax)

  • Time to maximum plasma concentration [ Time Frame: 12 Weeks Time to maximum plasma concentration ] [ Designated as safety issue: No ]
    To characterize the systemic exposure of apremilast (20 mg twice daily and 30 mg twice daily) based on the intensive pharmacokinetics at Week 12 (for example: blood draws at pre-dose and up to 8 hours post-dose): Time to maximum plasma concentration of apremilast (tmax)

  • Systemic Exposure [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    To characterize the systemic exposure of apremilast (20 mg twice daily and 30 mg twice daily) based on the population (sparse) Pharmacokinetic parameters, drug clearance and volume of distribution determined from samples collected at Weeks 4, 16 and 24


Enrollment: 237
Study Start Date: December 2010
Study Completion Date: September 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apremilast 30 mg Drug: Apremilast 30 mg
30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
Other Name: CC-10004
Experimental: Apremilast 20 mg Drug: Apremilast 20 mg
20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
Placebo Comparator: Placebo Drug: Placebo
Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders will advance early to 20 mg Apremilast BID at Week 16.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a documented diagnosis of Rheumatoid Arthritis (1987 American College of Rheumatology Criteria) with onset of signs/symptoms of disease ≥ 4 months of duration from randomization.
  • Must be receiving treatment on an outpatient basis.
  • Must have active disease despite current methotrexate treatment as defined below:

    • ≥ 6 swollen joints (66 swollen joint count) AND
    • ≥ 6 tender joints (68 tender joint count)

      -. Must meet at least one of the four lab requirements below:

    • High Sensitivity C-Reactive Protein (hsCRP) ≥ 10 mg/L
    • Erythrocyte Sedimentation Rate (ESR) > 28 mm after the first 1 hour
    • Positive for Rheumatoid Factor (RF)
    • Positive for Anti-cyclic Citrullinated Peptide (anti-CCP) antibodies
  • For participants participating in the Magnetic Resonance Imaging (MRI) assessment:

    • Must have Rheumatoid Arthritis joint involvement, as assessed by swollen joint counts in: 1) at least two Metacarpophalangeal (MCP) swollen joints on the same hand, or 2) at least one swollen Metacarpophalangeal (MCP) joint and swollen wrist on the same hand.

  • Must have been treated with methotrexate for at least 4 months prior to randomization, and must be on stable dose. Participants will be required to maintain their stable dose through Week 52 of the study. Oral folate (folic acid) supplementation is required with a minimum dose of 5 mg/week, or instead leucovorin may be used up to 10 mg/week orally.

    -. Non-steroidal anti-inflammatory drugs (NSAIDs) and pain medications are allowed, however, must be on stable regimen for at least 7 days prior to randomization and through Week 52 of the study.

  • Oral corticosteroids (if taken) are allowed, however, must be on stable dose of prednisone ≤ 10 mg/day or equivalent for at least 28 days prior to randomization and through Week 52 of the study.
  • Must meet the following laboratory criteria at screening:

    • White blood cell count ≥ 3000/mm^3 (≥ 3.0 x 10^9/L) and < 14,000/mm^3 (< 14 x 10^9/L)
    • Platelet count (≥ 100,000/μL ((≥ 100 x 10^9/L)
    • Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
    • Aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase or serum glutamic-pyruvic transaminase (ALT/ SGPT) ≤ 2 x upper limit of normal (ULN). If initial test shows Aspartate aminotransferase (AST) or alanine aminotransferase (SLT) or 2 times the upper limit of normal (ULN), one repeat test is allowed during the screening period.
    • Total bilirubin ≤ 2 mg/dL (≤ 34 μmol/L). If initial test result is > 2 mg/dL, one repeat test is allowed during the screening period.
    • Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L)
    • Hemoglobin A1c ≤ 9.0%
    • Negative for hepatitis B surface antigen
    • Negative for hepatitis C antibody
  • Males who engage in activity in which conception is possible must use protocol described barrier contraception while on Investigational Product and for at least 28 days after the last dose of Investigational Product.
  • Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use protocol described contraception while on Investigational Product and for at least 28 days after taking the last dose or Investigational Product.

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
  • Rheumatic autoimmune disease other than Rheumatoid Arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis or significant systemic involvement secondary to Rheumatoid Arthritis (eg, vasculitis, pulmonary fibrosis or Felty syndrome). Sjögren syndrome secondary to Rheumatoid Arthritis is allowable.
  • Functional Class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.
  • Prior history of, or current, inflammatory joint disease other than Rheumatoid Arthritis (eg, gout, reactive arthritis, psoriatic arthritis, ankylosing spondylitis, Lyme disease).
  • Receiving treatment with Disease-modifying antirheumatic drugs (DMARDs) (other than methotrexate), including biologic Disease-modifying antirheumatic drugs (DMARDs)Previous use is only allowed after adequate washout prior to randomization.
  • Inadequate response to treatment with an anti-tumor necrosis factor (anti-TNF) agent. Patients who terminated previous anti-tumor necrosis factor (anti-TNF) treatment due to cost or safety reason, such as discomfort with the subcutaneous injections, may participate in this study after adequate washout.
  • Treatment with any investigational agent within four weeks (or five half-lives of the investigational drug, whichever is longer) of screening.
  • Previous treatment with any cell depleting therapies, including investigational agents.
  • Treatment with intravenous gamma globulin, plasmapheresis or Prosorba® column within 6 months of baseline.
  • Intra-articular or parenteral corticosteroids are not allowed within 6 weeks prior to randomization.
  • Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.
  • Pregnant women or nursing (breast feeding) mothers.
  • Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including severe or very severe chronic obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus as defined by Hemoglobin A1c > 9.0%) or gastrointestinal (GI) disease.
  • Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids.
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding onychomycosis) or any major episode of infection requiring hospitalization or treatment with IV or oral antibiotics within 4 weeks of screening.
  • History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
  • History of malignancy, including solid tumors and hematologic malignancies (except basal cell carcinoma of the skin that has been excised and cured).
  • History of alcohol, drug or chemical abuse within the 6 months prior to screening.
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Any condition that in the investigator's opinion would interfere significantly with the efficacy evaluations, including the pain and joint assessments (eg, fibromyalgia).

For Magnetic Resonance Imaging (MRI) Only:

  • Receiving medication(s) or will require medication(s) during the study that impact on vascular flow (eg, nitrates, calcium channel blockers, ergot containing drugs) on the day of the Magnetic Resonance Imaging (MRI test and in the investigator's judgement the subject cannot hold back from taking these medications on the day of the Magnetic Resonance Imaging (MRI) prior to the Magnetic Resonance Imaging (MRI) test. The subject can continue taking the medication(s) at any time after the Magnetic Resonance Imaging (MRI) test is completed, as clinically indicated and scheduled. Exclusions of antihypertensive and migraine medications can be determined after discussion with the Sponsor.
  • Unable to undergo an Magnetic Resonance Imaging (MRI) examination, including but not limited to the presence of a pacemaker, defibrillator, or other implanted device such as anterior interbody cages, aneurysm clip, pedicle screws, or any other metal contained in the body (eg, such as tattoos that contain metallic pigment, or metal in the eyes from metal grinding [eg, a metal worker, etc]), or severe claustrophobia, or any other contraindication to an Magnetic Resonance Imaging (MRI) as per local imaging center guidelines.
  • Allergic or adverse reactions to gadolinium
  • Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2 (based on the Modification of Diet in Renal Disease [MDRD] formula).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285310

  Show 50 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Randall Stevens, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01285310     History of Changes
Other Study ID Numbers: CC-10004-RA-002, 2010-019926-15
Study First Received: November 19, 2010
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Celgene Corporation:
Rheumatoid, Arthritis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis
Arthritis, Rheumatoid
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014