Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00211887
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Fred Lublin
• Public title: Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx
• Scientific title: 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)
• Date of first enrolment: January 2005
• Target sample size: 1008
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00211887
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Fred Lublin, MD
• Affiliation: Icahn School of Medicine at Mount Sinai

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects between the ages of 18 and 60 years, inclusive.

- Diagnosis of relapsing-remitting MS by either the Poser or McDonald criteria.

- Expanded Disability Status Scale (EDSS) score between 0 and 5.5, inclusive.

- At least 2 exacerbations in the prior three years; one exacerbation may utilize the
McDonald MRI criteria for dissemination in time (a new gadolinium [Gd]-enhancing
lesion demonstrated on a scan done at least 3 months following onset of a clinical
attack or a new T2 lesion or Gd-enhancing lesion on a follow-up scan after an
additional 3 months).

- Give written informed consent prior to any testing under this protocol, including
screening tests and evaluations that are not considered part of the subject's routine
care.

Exclusion Criteria:

- Any prior use of interferon beta or glatiramer acetate.

- Acute exacerbation within 30 days of screening.

- Steroids for acute exacerbations (>100 mg/day) within 30 days of study entrance or
chronic systemic steroid use.

- Evidence of progressive MS.

- Use IVIg, azathioprine, methotrexate, cyclosporine, mitoxantrone, cyclophosphamide,
mycophenolate (CellCept) or plasma exchange in the twelve weeks prior to study drug
dosing.

- Any previous treatment with natalizumab (Tysabri, Antegren), cladribine, T cell
vaccine, Campath, daclizumab, rituximab, altered peptide ligand or total lymphoid
irradiation.

- Treatment with 4 aminopyridines in the four weeks prior to study drug dosing.

- Prior treatment with any other investigational drug, unless approved by the Clinical
Coordinating Center (Dr. Lublin).

- Inability to perform the baseline MSFC (timed 25-foot walk, 9-hole peg test [9HPT],
and Paced Auditory Serial Addition Test 3 [PASAT3]).

- Inability to undergo baseline MRI scan.

- History of any significant cardiac, hepatic, pulmonary, or renal disease, immune
deficiency, or other medical conditions that would preclude therapy with interferon
beta, glatiramer acetate, or participation in this study.

- Known history of sensitivity to gadopentetate dimeglumine or mannitol.

- History of a seizure within the 3 months prior to randomization.

- History of suicidal ideation or an episode of severe depression within the 3 months
prior to randomization.

- Abnormal screening blood tests exceeding any of the limits defined below:

- Alanine transaminase (ALT) or aspartate transaminase (AST) greater than two times
the upper limit of normal (i.e., >2 × ULN)

- Total white blood cell count <2,300/mm3

- Platelet count <80,000/mm3

- Creatinine >2 × ULN

- Participation in another experimental clinical trial, without formal approval.

- History of alcohol or drug abuse within the 2 years prior to randomization.

- Female subjects who are currently pregnant, breast-feeding, or plan to become
pregnant.

- For female subjects, unless postmenopausal or surgically sterile, unwillingness to
practice effective contraception, as defined by the investigator, during the study.
The rhythm method is not to be used as the sole method of contraception.

- Unwillingness or inability to comply with the requirements of this protocol including
the presence of any condition that is likely to affect the subject's returning for
scheduled follow-up visits on schedule (any physical, mental, or social condition).



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: glatiramer acetate

Drug: Interferon beta 1-a

Other: placebo

Primary Outcome(s)

ARR - PDEs [Time Frame: Baseline to Month 36]

Secondary Outcome(s)

Change in MRI Composite Score [Time Frame: Baseline to month 36]

Confirmed Progression on the Expanded Disability Status Scale [Time Frame: Baseline to Month 36]

Change in the Multiple Sclerosis Functional Composite [Time Frame: Baseline to month 36]

Secondary ID(s)

U01NS045719

GCO 02-0526

02-0526

CRC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)

Results

• Results available: Yes
• Date Posted: 03/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00211887