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Ankylosing SpondylitisPhase 2NCT02201043

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

A Phase 2 study testing Thalidomide 150mg and Thalidomide 100mg in people with Ankylosing Spondylitis, run by Shanghai Pharmaceuticals Holding Co., Ltd at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Thalidomide 150mg and Thalidomide 100mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
197 participants
Where
9 sitesChina
Study dates
Feb 2013to Feb 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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.

Who cannot join

  • (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;
Show all 22Show fewer
  • (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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • The General Hospital of People's Liberation Army

    Beijing, Beijing Municipality, 100853

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Guanghua Hospital

    Shanghai, Shanghai Municipality, 200052

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • The Xinjiang Uygur Autonomous Region people's Hospital

    Ürümqi, Xinjiang, 830001

  • Xijing Hospital

    XiAn, Shanxi, 710032

Other trials in China

About this study

Official title: 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.
Being tested
Thalidomide 150mg, Thalidomide 100mg, Placebo
Keywords
ankylosing spondylitis, thalidomide
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thalidomide 150mgDrug

    Also called Thalomid, Fan Ying Ting

  • Thalidomide 100mgDrug

    Also called Thalomid, Fan Ying Ting

  • PlaceboDrug

Study groups in NCT02201043
Study groupRoleWhat they receive
Thalidomide 150mgActive comparatorThalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end
Receives: Drug: Thalidomide 150mg
Thalidomide 100mgActive comparatorThalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end
Receives: Drug: Thalidomide 100mg
PlaceboPlacebo comparatorPlacebo po.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: week 12

Secondary outcomes (14)

  1. Change of ASDAS score

    Measured: week 12

  2. Change of ASDAS score

    Measured: week 24

  3. Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Measured: week 24

  4. Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)

    Measured: week 24

  5. Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)

    Measured: week 24

  6. Mean change from baseline in back pain using a Visual Anolog Scale(VAS)

    Measured: week 24

  7. Morning stiffness

    Measured: week 24

  8. Number of Peripheral swollen joints

    Measured: week 24

  9. Number of Peripheral joint tenderness

    Measured: week 24

  10. Chest expansion

    Measured: week 24

  11. ESR

    Measured: week 24

  12. CRP

    Measured: week 24

  13. Schober test

    Measured: week 24

  14. Scoliosis

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2014 (estimated)
  2. Study startFeb 2013
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02201043
Sponsor's protocol ID
SLDA-201
Status last verified
Nov 2015
First submitted
23 Jul 2014
Last updated
20 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Thalidomide 150mg and Thalidomide 100mg in people with Ankylosing Spondylitis, run by Shanghai Pharmaceuticals Holding Co., Ltd at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02201043.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.

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