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

November 17, 2015 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

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

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • the First Affiliated Hospital of Bengbu Medical College
    • Beijing
      • BeiJing, Beijing, China, 100853
        • The General Hospital of People's Liberation Army
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, Shanghai, China, 200052
        • Shanghai Guanghua Hospital
    • Shanxi
      • XiAn, Shanxi, China, 710032
        • Xijing Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital
    • Xinjiang
      • Wulumuqi, Xinjiang, China, 830001
        • The Xinjiang Uygur Autonomous Region people's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Thalidomide 150mg
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end
Drug: Thalidomide 150mg
Other Names:
  • Thalomid
  • Fan Ying Ting
Active Comparator: Thalidomide 100mg
Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end
Drug: Thalidomide 100mg
Other Names:
  • Thalomid
  • Fan Ying Ting
Placebo Comparator: Placebo
Placebo po.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
Time Frame: week 12
week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change of ASDAS score
Time Frame: week 12
week 12
Change of ASDAS score
Time Frame: week 24
week 24
Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: week 24
week 24
Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)
Time Frame: week 24
week 24
Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)
Time Frame: week 24
week 24
Mean change from baseline in back pain using a Visual Anolog Scale(VAS)
Time Frame: week 24
week 24
Morning stiffness
Time Frame: week 24
week 24
Number of Peripheral swollen joints
Time Frame: week 24
week 24
Number of Peripheral joint tenderness
Time Frame: week 24
week 24
Chest expansion
Time Frame: week 24
week 24
ESR
Time Frame: week 24
week 24
CRP
Time Frame: week 24
week 24
Schober test
Time Frame: week 24
week 24
Scoliosis
Time Frame: week 24
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SLDA-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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