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

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Thalidomide 150mg
Thalidomide 100mg
Placebo
Sponsored by
Shanghai Pharmaceuticals Holding Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, thalidomide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • The General Hospital of People's Liberation Army
  • Zhongshan Hospital Fudan University
  • Shanghai Guanghua Hospital
  • Changhai Hospital
  • Xijing Hospital
  • West China Hospital of Sichuan University
  • Sichuan Provincial People's Hospital
  • The Xinjiang Uygur Autonomous Region people's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Thalidomide 150mg

Thalidomide 100mg

Placebo

Arm Description

Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end

Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end

Placebo po.

Outcomes

Primary Outcome Measures

Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)

Secondary Outcome Measures

Change of ASDAS score
Change of ASDAS score
Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)
Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)
Mean change from baseline in back pain using a Visual Anolog Scale(VAS)
Morning stiffness
Number of Peripheral swollen joints
Number of Peripheral joint tenderness
Chest expansion
ESR
CRP
Schober test
Scoliosis

Full Information

First Posted
July 23, 2014
Last Updated
November 17, 2015
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02201043
Brief Title
Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
ankylosing spondylitis, thalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thalidomide 150mg
Arm Type
Active Comparator
Arm Description
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end
Arm Title
Thalidomide 100mg
Arm Type
Active Comparator
Arm Description
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo po.
Intervention Type
Drug
Intervention Name(s)
Thalidomide 150mg
Other Intervention Name(s)
Thalomid, Fan Ying Ting
Intervention Type
Drug
Intervention Name(s)
Thalidomide 100mg
Other Intervention Name(s)
Thalomid, Fan Ying Ting
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Change of ASDAS score
Time Frame
week 12
Title
Change of ASDAS score
Time Frame
week 24
Title
Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame
week 24
Title
Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)
Time Frame
week 24
Title
Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)
Time Frame
week 24
Title
Mean change from baseline in back pain using a Visual Anolog Scale(VAS)
Time Frame
week 24
Title
Morning stiffness
Time Frame
week 24
Title
Number of Peripheral swollen joints
Time Frame
week 24
Title
Number of Peripheral joint tenderness
Time Frame
week 24
Title
Chest expansion
Time Frame
week 24
Title
ESR
Time Frame
week 24
Title
CRP
Time Frame
week 24
Title
Schober test
Time Frame
week 24
Title
Scoliosis
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
The General Hospital of People's Liberation Army
City
BeiJing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Guanghua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200052
Country
China
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Xijing Hospital
City
XiAn
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
The Xinjiang Uygur Autonomous Region people's Hospital
City
Wulumuqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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