Department of Neurology

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A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients with Relapsing Remitting Multiple Sclerosis (CombiRx-Phase III).                                         

Study duration
The treatment phase of the study will be for 36 weeks.

Key Inclusion Criteria

  1. Age range: 18 to 60 years inclusive. Based on epidemiological data, the vast majority of the RR-MS cohort that will be enrolled in this trial will be between 20-40 years of age with a peak around 27-35 years.
  2. Sex: the male to female ratio in RR-MS patients is 2:3. Enrollment of the control group should therefore aim at the same sex distribution.
  3. Ethnicity: while no ethnic group shall be excluded from the control group, epidemiological data indicate that the ethnic composition of RR-MS patients will be 80-90% Caucasian, and, within the remaining 10-20% equal proportions of African Americans and Hispanic individuals and a smaller fraction of Asians, Pacific Islanders or other ethnic groups.
  4. HLA type: While a composition of the control group with respect to MS-associated HLA-class II molecules, particular presence of the HLA-DR15 haplotype (DRB1*1501, DRB5*0101, DQA1*0102, DQB1*0602), is desirable, an HLA-based inclusion criteria would be impractical. Approximately 25-30% of the individuals within the healthy target population will express the HLA-DR15 haplotype, while approximately 50-60% of the RR-MS patients will be hetero- or homozygote for the DR15 haplotype. Stratification for HLA can be performed for the control population once HLA typing has been done.
  5. Geographical distribution: The geographical origin of the control population should be consistent with the origin of the RR-MS study population. A subset of centers that reflects the geographical distribution of the study centers participating in the Combi-Rx parental treatment study for the BioMS protocol will be identified and asked for participation to provide control samples. The tentative list of centers is attached (attachment B). The final list of centers will be reported to the NINDS IRB, once they have agreed to participate.
  6. Other considerations: the time of enrollment of the control population shall parallel that of the enrollment phase for the patients in the Combi-Rx trial. It has to be avoided that study material from the control population are acquired with a bias in terms of time of blood-draw, i.e. the control samples can not be drawn together before or after or in any form out of synchronization with the materials derived from the patients. Furthermore, the sample collection kits, sample handling, shipping, and methods of isolation will be identical to the procedures applied to the patient samples.

Key Exclusion Criteria

  1. Any significant acute or chronic illness, particularly no autoimmune or chronic inflammatory, infectious disease.
  2. HIV positive.
  3. No treatment with immunomodulatory, immunosuppressive or chemotherapeutic drugs.
  4. Pregnancy.
  5. Pregnant women are excluded from the CombiRX trial because they are receiving therapy which is contraindicated in pregnancy. Consequently controls must be selected from non pregnant women since pregnancy may alter gene expression. Pregnancy will be excluded by history.
  6. Nursing mothers.

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