A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease

What Was Tested

The trial (phase 2) is built around Glatiramer Acetate.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Placebo subcutaneous injection(daily through week 12).

The registry classes the interventions as drug.

More on the Plan

Patients requiring colonoscopy according to Physicians decision would also be offered to participate in an endoscopic mucosal healing evaluation substudy.

Patients participating will undergo colonoscopy and biopsies at the beginning (screening±1 week) and the end (week 12±1 week) of the treatment period.

Immunologic assessment (including lymphocyte proliferation and cytokine secretion assays) will be performed at the baseline visit as well as weeks 4 and 12 and 16.

Serum samples for cytokine studies 24 hours after first injection would also be collected.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Are 18-70 years old at the time of screening; may be male or female. Have Crohn's disease, diagnosed more than 3 months before enrollment and confirmed by endoscopy, radiology or surgery. Documentation should be performed within 36 months prior to screening. Moderately active Crohn's disease as indicated by a CDAI 220 - 450. Are able to adhere to the following concomitant medication requirements:. Patients must never have received treatment with Copaxone.

The full record lists 13 inclusion and 13 exclusion criteria; among the exclusions: diagnosis of indeterminate, microscopic, lymphocytic, collagenous, or ulcerative colitis; short bowel syndrome or a bowel surgery within 3 month before randomization; the use of the following medications within the last 12 weeks prior to screening: tnf-a antibodies, thalidomide, methotrexate, cyclosporine, tacrolimus, or mycophenolate mofetil.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Glatiramer Acetate study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2008-09 with completion listed for 2010-07.

It ran at 2 sites in Israel (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Primary endpoints: The proportion of patients at clinical remission (CDAI<150) (time frame: week 12).

It also tracked 1 secondary outcome, for example Proportion of patients at clinical remission.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, all human trials.