Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201043
• Other study ID #: SLDA-201
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2014
• Last updated: November 17, 2015
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: November 2015
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis.

2. To explore dose-effect relationships of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis, as well as selecting the appropriate dose for the further larger scale clinical trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• (1) Active Ankylosing Spondylitis, Age 18-65, both outpatient or inpatient, both gender;

• (2) AS patients after traditional therapy (Using NSAIDs in a stable dose for 1 month, using oral corticosteroids, using NSAIDs for 3 months) still in active stage;

• (3) Pregnancy test must be negative in the female subjects of childbearing age or wife of the male subjects;

• (4)Female subjects with fertility during the trial (of 32 weeks) agreed to take a double medically accepted and reliable contraceptive measures, which includes a drug and a non-drug contraceptive measures; if the spouses of male subjects have fertility, agreed to use latex condoms for contraception;

• (5)Willing to have the treatment according to the plan as well as do the follow-up exam on time;

• (6)Understand and voluntarily signed informed consent.

Exclusion Criteria:

• (1) Suffering from or have suffered from rheumatoid arthritis, disc prolapse, septic arthritis, diffuse idiopathic skeletal hyperostosis syndrome, iliac dense osteitis, psoriatic arthritis, bowel disease arthritis, Reiter syndrome;

• (2) Severe AS, spine completely stiff (X-ray class IV) or the disease has been shown to have a shorter survival period;

• (3) Previously had total hip arthroplasty surgical treatment or appropriate to have the surgery;

• (4) Previously received anti-TNF therapy;

• (5) Used leflunomide within 3 months before screening;

• (6) Severe or persistent infection requires antimicrobial therapy;

• (7) Hepatitis B surface antigen or hepatitis C antibody test positive;

• (8) HIV positive or have acquired immunodeficiency syndrome (AIDS) history;

• (9) Malignancy, lymphoproliferative disease history;

• (10) Severe diabetes;

• (11) Resting hypotension (BP<90/50 mmHg) or hypertension (BP>170/100 mmHg), and orthostatic hypotension and clinically significant ECG abnormalities;

• (12) Over the past six months had a stroke, heart attack or other serious cardiovascular disease (including heart failure, unstable angina or life-threatening arrhythmias and coronary artery bypass graft surgery);

• (13) WBC or neutrophils below the lower limit of normal;

• (14) Liver dysfunction, AST or ALT l> 2 times the upper limit of normal;

• (15) Renal dysfunction, Cr>2 times the upper limit of normal;

• (16) Female subjects or spouses of male subjects have positive pregnancy test or be in the sickling period or intend to fertility or unwilling to take effective contraception;

• (17) With clinical symptoms of serious drug abuse or alcohol abuse or mental illness history;

• (18) Participated in any clinical trials of drugs within 3 months before screening;

• (19) Workers engaged in dangerous (eg drivers, machine operator, high-altitude operations, etc.);

• (20) A history of deep venous thrombosis or pulmonary embolism;

• (21) Be allergic to Test drug ingredients (including excipients);

• (22) Other reasons for not be enrolled.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Thalidomide 150mg

• Thalidomide 100mg

• Placebo

Locations

Country	Name	City	State
China	The General Hospital of People's Liberation Army	BeiJing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Changhai Hospital	Shanghai	Shanghai
China	Shanghai Guanghua Hospital	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	The Xinjiang Uygur Autonomous Region people's Hospital	Wulumuqi	Xinjiang
China	Xijing Hospital	XiAn	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)		week 12	No
Secondary	Change of ASDAS score		week 12	No
Secondary	Change of ASDAS score		week 24	No
Secondary	Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)		week 24	No
Secondary	Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)		week 24	No
Secondary	Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)		week 24	No
Secondary	Mean change from baseline in back pain using a Visual Anolog Scale(VAS)		week 24	No
Secondary	Morning stiffness		week 24	No
Secondary	Number of Peripheral swollen joints		week 24	No
Secondary	Number of Peripheral joint tenderness		week 24	No
Secondary	Chest expansion		week 24	No
Secondary	ESR		week 24	No
Secondary	CRP		week 24	No
Secondary	Schober test		week 24	No
Secondary	Scoliosis		week 24	No