Azathioprine as an adjuvant therapy in severe Graves’ disease: A new perspective
- Conditions
- Nutritional, Metabolic, Endocrine
- Registration Number
- PACTR201912487382180
- Lead Sponsor
- Alexandria University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 163
a.Aged 18-75 years.
b.Interested and willing to participate in the study.
c.newly diagnosed Graves' disease with severe hyperthyroidism and do not be treated with anti-thyroid medications.
Severe hyperthyroidism was defined in patients who have one or more of the following items:
•Those who are extremely symptomatic especially with heart rate?>?120 b/min, got hyperthyroid heart disease, or loss of weight?>?10?kg,
•patients who have free T4 or free T3 estimates 2–3 times the upper limit of normal. (FT4 = 3.6 ng/dL,or FT3 = 8.4 pg/mL, respectively)
d.If a female in the childbearing period must:
i.neither be pregnant nor breastfeeding nor attempting to conceive.
ii.use a highly effective method of contraception throughout the entire duration of the study and for at least 90 days after the last dose of azathioprine.
iii.A serum pregnancy test will be performed at the first screening visit.
a-End stage diseases.
b-Live vaccines within the past 3 months
c-Haemoglobin concentration < 12 g/dl ; platelet count < 130 × 109/L. White cell count below the local laboratory's reference range; Lymphocyte count < 0.8 × 109/L
d-Known history of active or chronic infectious disease or any disease which compromises immune function (e.g. HIV+, HTLV-1, Latent or active TB, Hepatitis).
e-A known history of hypersensitivity reactions to Aza.
f-Signs of moderate or severe orbitopathy including optic nerve compression requiring steroids and/or a clinical activity score >3.
g-Treatment with steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone with the exception of inhaled steroids within the three months prior to Study Day 1.
h-Patients require urgent treatment of thyrotoxicosis.
i.Significant cardiac disease and/or atrial fibrillation
ii.Symptoms and signs of thyroid storm.
iii.Large and compressive goiters causing localized symptoms such as difficulty swallowing or breathing
i-The use of azathioprine, or participation in any Clinical Trial within three months prior to Study Day 1.
j-Treatment with any cytokine or anti-cytokine therapy within three months prior to Study Day 1.
k-Inadequate liver function, defined by total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase
(ALT) or alkaline phosphatase > 3 times the upper limit of the normal values at the screening visit.
l-Subject with any significant medical illness or psychiatric condition would preclude participation in the study or impair the ability to give informed consent; any other clinically apparent autoimmune disease.
M- pregnant or lactating females. Also, females attempting to conceive will be excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of remission <br>Complete remission: is defined as keeping euthyroid with negative TRAB and without receiving any ATD for at least 12 months. <br>Partial remission: is defined as keeping euthyroid with receiving low-dose MMI (i.e 5mg/d) for at least 12 months.<br>
- Secondary Outcome Measures
Name Time Method The duration of treatment required for serum thyroid hormones concentration (TSH, FT3, and FT4) to normalize (0.39 – 4.16 mIU/L, 1.4-4.2 pg/mL, and 0.8-1.8 ng/dL, respectively).;The rate of relapse (recurrence of hyperthyroidism) within a follow-up of at least 12 months after cessation of treatment;Change in total thyroid volume ;The medical costs in all groups;safety and tolerability of combination of AZA and carbimazole