ABBOTT PARK, Illinois, March 30, 2011 /PRNewswire/ --
Abbott (NYSE: ABT) announced today it enrolled the first patient in the CALM Study, a clinical trial with HUMIRA(R) (adalimumab), to determine if tailoring therapy to more stringent measures of disease activity in patients with early moderate to severe Crohn's disease will improve mucosal healing. The study will assess patients monitored with those stringent criteria over 56 weeks compared to patients monitored with less stringent and more commonly used clinical disease management criteria. This international study is enrolling now in Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and the UK with the goal to research the response rates of approximately 240 people diagnosed with Crohn's disease for less than four years who have had no more than one course of corticosteroids and are naive to immunosuppressive and biologic therapy.
"We know Crohn's disease can be difficult to treat and that early intervention may yield improved long-term outcomes," said Professor Jean-Frederic Colombel, head of Gastroenterology, University of Lille, France. "There are a number of objective measures by which we can quantify a therapy's effect. Assessing these important objective measurement tools may provide valuable information for physicians managing this disease."
The CALM study will evaluate tight control of disease activity, defined as using stringent criteria based on the Crohn's disease activity index (CDAI), high sensitivity C-reactive protein levels, the fecal Calprotectin test and the need for continued corticosteroid use, versus disease management based only on CDAI and corticosteroid use.
"The tight-control approach may offer a benchmark for drug therapies relative to symptomatic treatment," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "These important measures may provide strides toward understanding and defining objective disease management tools for Crohn's patients."
About the CALM Study
The CALM Study, an Open-Label, Multi-Center, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease, is a 56-week, multicenter, randomized, safety and efficacy trial of prednisone, HUMIRA, and azathioprine using tight control versus clinically driven management of Crohn's disease to evaluate mucosal healing in subjects with moderately to severely active Crohn's disease, who are naive to immunosuppressive and biologic therapy. Males and females ages 18 to 75 will be enrolled at approximately 60 international study sites across Europe and Canada. Eligible patients will have been diagnosed with Crohn's disease using imaging technology or endoscopy not more than four years prior to enrolling. They will have some degree of inflammation measured by high sensitivity C-reactive protein level and fecal Calprotectin test. Additionally, participants should not have any previous or current use of biologics for Crohn's disease and should not have taken more than one previous course of a corticosteroid.
About Crohn's Disease
Crohn's disease is a serious chronic inflammatory autoimmune disorder of the gastrointestinal tract. It most commonly affects the end of the small intestine or the ileum, however, it may involve any part of the gastrointestinal tract. Symptoms can range from diarrhea, abdominal pain and fever to rectal bleeding.
Important Treatment Considerations
Globally, prescribing information varies; refer to the individual country product label for complete information.
HUMIRA is used to reduce the signs and symptoms of Crohn's disease (CD) in adults who have not responded well to conventional treatments.
Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, or viral pathogens, rare cases of tuberculosis (TB), and other opportunistic infections, including fatalities, have been reported with the use of TNF-antagonists, including HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease could predispose them to infections. Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with HUMIRA should be considered prior to initiating therapy. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. If latent tuberculosis is diagnosed, appropriate treatment for latent tuberculosis must be initiated with anti-tuberculosis prophylaxis therapy before starting treatment with HUMIRA, and in accordance with local recommendations. Patients who develop new infections while using HUMIRA should be monitored closely and undergo a complete diagnostic evaluation. HUMIRA should be discontinued if a patient develops a new serious infection or sepsis, until the infection is controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.
TNF-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA. Carriers of HBV who are treated with HUMIRA should be closely monitored for active HBV infection throughout therapy and for several months following termination of therapy.
TNF-antagonists, including HUMIRA, have been associated in rare cases with demyelinating disease including multiple sclerosis. Serious allergic reactions have been reported very rarely following HUMIRA administration.
More cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients in clinical trials. However, the occurrence was rare. Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation. With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Rare postmarketing cases of hepatosplenic T-cell lymphoma, a disease with a very aggressive and usually fatal outcome, have been identified in patients treated with adalimumab. Some of these cases occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for Crohn's disease. A risk for the development of hepatosplenic T-cell lymphoma in patients treated with HUMIRA cannot be excluded.
All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, should be examined for the presence of non-melanoma skin cancer prior to and during treatment with HUMIRA.
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-blocking agents. Adverse events of the haematologic system, including medically significant cytopenia have been infrequently reported with HUMIRA.
Patients on HUMIRA may receive concurrent vaccinations, except for live vaccines. Juvenile patients should be brought up to date with all immunisations prior to initiating HUMIRA therapy, if possible.
In clinical studies with another TNF-antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA. Physicians should exercise caution when using HUMIRA in patients with heart failure and monitor them carefully.
The combination of HUMIRA and anakinra or HUMIRA and abatacept is not recommended.
Adverse Events at least possibly causally related to HUMIRA include very common events (reported by >1/10 patients) respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis, pneumonia herpes viral), leucopaenia (including neutropaenia, agranulocytosis), anaemia, lipids increased, headache, abdominal pain, nausea and vomiting, liver enzymes elevated, rash (including exfoliative rash), musculoskeletal pain, injection site reaction (including injection site erythema); common events (reported by >1/100 but < 1/10 patients): systemic infections (including sepsis, candidiasis, influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis, herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes, tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, benign neoplasm, skin cancer excluding melanoma (including basal cell carcinoma, squamous cell carcinoma), thrombocytopaenia, leucocytosis, hypersensitivity, allergies (including seasonal allergy), hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycemia, hypophosphotemia, blood potassium increased, mood alterations (including depression), anxiety, insomnia, paraesthesias (including hypoaesthesia), migraine, sciatica, visual impairment, conjunctivitis, vertigo, tachycardia, hypertension, flushing, haematoma, cough, asthma, dyspnoea, GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome, pruritus, urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhydrosis, muscle spasms (including blood creatine phosphokinase increased), haematuria, renal impairment, chest pain, oedema, coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased, impaired healing.
Adverse drug reactions reported post-marketing include hepatosplenic T-cell lymphoma, anaphylaxis, demyelinating disorders (including optic neuritis, Guillain-Barre syndrome), cerebrovascular accident, intestinal perforation, reactivation of hepatitis B, cutaneous vasculitis, Stevens-Johnson syndrome, angioedema, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis), lupus-like syndrome, and myocardial infarction.
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