Clinical trial: Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) (NCT00106184)

Eligibility criteria:
Inclusion Criteria:

          -  Adults with definite or probable dermatomyositis or polymyositis and pediatric
             patients five years of age and over with definite or probable juvenile dermatomyositis
             (JDM) by Bohan and Peter criteria. Diagnosis of JDM based on an age of onset (i.e.,
             first symptom of myositis or dermatomyositis rash) is less 18 years of age

          -  Refractory myositis, defined by intolerance to or inadequate response to
             corticosteroids plus an adequate regime of at least one other immunosuppressive agent.
             Intolerance is defined as side effects that require discontinuation of the medication
             or an underlying condition that precludes further use of the medication.

          -  Baseline manual muscle testing which is based on a maximum MMT-8 (Manual Muscle Test)
             score of 150:Adult subjects with dermatomyositis (DM) or polymyositis (PM) must have a
             score that is no greater than 125/150 in conjunction with 2 other abnormal core set
             measures.

        Subjects with a diagnosis of Juvenile Dermatomyositis (JDM) must meet either of the
        following criteria:

          1. An MMT-8 (Manual Muscle Test) score that is no greater than 125/150 in conjunction
             with 2 other abnormal core set measures.

             OR

          2. If MMT (Manual Muscle Test) score is greater than 125/150 the patient MUST meet at
             least 3 abnormal core set measures.

               -  Background therapy with at least 1 non-corticosteroid immunosuppressive agent at
                  a stable dose for at least 6 weeks prior to screening

               -  Able and willing to complete self-report questionnaires. Parents of pediatric
                  participants will be required to complete the questionnaires on behalf of their
                  children.

               -  Willing to use acceptable forms of contraception for the duration of the study
                  for patients of reproductive potential.

               -  Parent willing to provide informed consent, if applicable

               -  Willing to forgo immunization with a live vaccine for the duration of the study

        Exclusion Criteria:

          -  Drug-induced myositis. Patients who have myositis or myopathic syndromes caused by
             taking medications known to induce myositis-like syndromes, including but not limited
             to statin agents, fibric acid derivatives, colchicine, and hydroxychloroquine.

          -  Juvenile polymyositis

          -  Inclusion body myositis

          -  Cancer-associated myositis, defined as the diagnosis of myositis within 2 years of the
             diagnosis of cancer. Patients with basal or squamous cell skin cancer or carcinoma in
             situ of the cervix are not excluded, if it has been at least 5 years since excision.

          -  Myositis in overlap with another connective tissue disease that may preclude the
             accurate assessment of a treatment response

          -  Live viral vaccine within 4 weeks prior to study entry

          -  Any joint disease or other musculoskeletal condition that may interfere with muscle
             strength testing

          -  Known hypersensitivity to mouse proteins

          -  Any concomitant or life-threatening non-myositis illness that, in the opinion of the
             investigator, may interfere with the study

          -  Known or suspected history of drug or alcohol abuse within the last 6 months prior to
             study entry, as determined by medical record or patient interview

          -  Anticipated poor compliance with study requirements

          -  Participation in another clinical trial within 30 days prior to screening

          -  Any history or evidence of any severe illness or other condition that, in the opinion
             of the investigator, may interfere with the study

          -  Previously received rituximab

          -  Evidence of prior infection with hepatitis B or hepatitis C virus

          -  Initiation of an exercise program within 4 weeks of screening OR initiation of an
             exercise program during the study

          -  Consumed any creatine-containing, over-the-counter products in the form of dietary
             supplements 30 days prior to screening visit and for the duration of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.


Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction