thalidomide and Chronic Illness

thalidomide has been researched along with Chronic Illness in 94 studies

Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.

Research

Studies (94)

Authors

Clinical Trials (10)

Trial Overview

Trial Outcomes

"Change From Baseline in Mechanically Evoked (Allodynia) Numeric Rating Scale (NRS) Score at Week 12"

The investigator rated the degree of allodynia on both the CRPS-affected limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the baseline values for the CRPS affected-limb to the values at week 12. Negative change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12

Participants rated how the activity level on a given day compares with their activity level prior to the start of treatment. A seven-point scale is used with -3=much worse and +3=much better. Positive change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in Daily Sleep Assessment Average Score at Week 12

Participants rated how much CRPS pain interfered with their sleep each day in a diary. The Sleep Assessment uses an eleven point scale for four questions. Questions concern ability to fall asleep, ability to stay asleep, how refreshed the participant feels upon waking and how alert the participant is during the day. All use a scale of 0-10, where the higher number is the positive response (e.g. 0=Pain completely interferes with sleep and 10=Pain does not interfere). The mean of all four responses was calculated if at least 3 of the 4 questions had a value. Week 12 values are compared to baseline values. Positive change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12

Participants rated twelve CRPS symptoms using a four-point rating scale in which 1=the most positive outcome and 4= the most negative outcome for a total scale of 12-48. Week 12 values are compared to baseline values. Negative change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Brief Pain Inventory (BPI) Total Score at Week 12

Participants completed the Brief Pain Inventory which asks twelve questions that are rated on an eleven-point scale in which 0=most positive outcome and 10=the most negative outcome for a total scale of 0-120. BPI contains questions that concern the level of pain over the last week and the level of pain right now, the extent to which pain interfered with sleep, normal activities, ability to work, relationships, walking etc. Week 12 values are compared to baseline values. Negative change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score Using Averaged Morning and Evening Readings at Week 12

Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. Morning and evening scores are averaged. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12

Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The evening pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Maximal Composite Motor Nerve Conduction Velocity at Week 12

An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal motor nerve conduct velocity. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Maximal Composite Sensory Nerve Conduction Velocity at Week 12

An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal sensory nerve conduct velocity. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12

Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The morning pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Profile of Mood States (POMS) at Week 12

Participants completed the Profile of Mood States questionnaire that asks participants to rate how each of 65 words reflected their mood in the past week on a 5-point scale with 0=not at all and 4=extremely for a total scale of 0-260. Week 12 values are compared to baseline values. Negative change values indicate improvement. (NCT00109772)
Timeframe: Day 0, week 12

Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12

Short Form McGill Pain Questionnaire (SF-MPQ) is comprised of 15 pain qualities that are rated by the participant on a 4 point scale with 0=none and 3=severe. The scale for the Total Score is 0-45. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain. (NCT00109772)
Timeframe: Day 0, week 12

Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12

The investigator rated the degree of allodynia on both the CRPS-affected limb and the normal (or less-affected) limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the values for the CRPS affected-limb to the normal limb at week 12. (NCT00109772)
Timeframe: Week 12

Patient Global Impression of Change (PGIC) at Week 12

The Patient Global Impression of Change asks the question: Overall, how would you rate your CRPS condition since the start of study drug? Answers are represented on a seven-point scale with -3=much worst and +3=much better. (NCT00109772)
Timeframe: Week 12

Participants Who Had a Change to CRPS Pain Medication During the Treatment Period

Participants who had any change in CRPS medication during the double-blind treatment period (up to week 12) are summarized. Changes include additions, discontinuations or dosage change of CRPS medication(s). (NCT00109772)
Timeframe: Day 1 to week 12

Participants With Treatment-Emergent Adverse Events in the Double-Blind Period or the Extension Period

"Counts of study participants who had adverse events (AEs) while treated in either the Double-blind or Extension Periods. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 was used by the investigator to grade the severity of the AEs: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.~AEs are also summarized by whether they were serious, related to treatment and whether the AE caused treatment to be altered.~A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above." (NCT00109772)
Timeframe: Day 1 up to week 158

Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment

Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Responders are participants who completed 12 weeks of treatment and their week 12 PI-NRS score showed at least a 30% improvement from baseline. Participants who did not complete 12 weeks of treatment are considered non-responders. (NCT00109772)
Timeframe: Day 0, Week 12

Apparent Terminal Elimination Rate Constant of Lenalidomide

Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Apparent Total Plasma Clearance (CL/F) of Lenalidomide

Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Apparent Volume of Distribution (VzF) of Lenalidomide

Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide

Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1. (NCT00812968)
Timeframe: Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide

Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.

Maximum Observed Plasma Concentration (Cmax) of Lenalidomide

Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Terminal Half-life (T1/2) of Lenalidomide

The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Time to Maximum Plasma Concentration (Tmax) of Lenalidomide

Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Change From Baseline in Hemoglobin Concentration

Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders. (NCT00812968)
Timeframe: Baseline and from Day1 until the maximum observed value (up to 155 weeks)

Change From Baseline in Percentage of Bone Marrow Erythroblasts

Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section. (NCT00812968)
Timeframe: Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).

Duration of Erythroid Response

Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response. (NCT00812968)
Timeframe: From the first dose of study drug through Week 156

Number of Participants With a Cytogenetic Response

"Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.~A major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period." (NCT00812968)
Timeframe: Response was assessed every 12 weeks through Week 156

Number of Participants With a Erythroid Response

"Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.~A major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin < 10 g/dL at Baseline a major response is defined as a > 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.~Minor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days." (NCT00812968)
Timeframe: Response was assessed every 28 days through Week 156.

Number of Participants With a Neutrophil Response

"Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase or a ≥ 500/mm^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.~A minor response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase, but an absolute increase < 500/mm^3, sustained for consecutive 56 days during the treatment period." (NCT00812968)
Timeframe: Response was assessed every 28 days through Week 156

Number of Participants With Adverse Events (AE)

"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event.~The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.~The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death." (NCT00812968)
Timeframe: After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).

Percentage of Bone Marrow Myeloblasts

Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section. (NCT00812968)
Timeframe: Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).

Percentage of Bone Marrow Promyelocytes

Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section. (NCT00812968)
Timeframe: Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).

Time to Erythroid Response

Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response. (NCT00812968)
Timeframe: From the first dose of study drug through Week 156

Mean Percentage Change in Total Surface Area of Oral Ulceration.

Mean percentage change in total surface area of oral ulceration (NCT00075023)
Timeframe: baseline to 4 weeks

Serum Levels of Hydroxycloroquine

Serum levels of hydroxycloroquine by LCMS (NCT03122431)
Timeframe: 12 months

Serum Levels of Thalidomide

Serum levels of thalidomide by liquid chromatography and tandem mass spectrometry (HPLC-MS/MS) (NCT03122431)
Timeframe: 12 months

Reviews

20 reviews available for thalidomide and Chronic Illness

Trials

20 trials available for thalidomide and Chronic Illness

Other Studies

54 other studies available for thalidomide and Chronic Illness